Dmp9196021-011_c.book Page 85 Wednesday, April 3, 2002 5:04 PM 85 Fill the Pump with insulin 1. Remove another refill syringe (IN2) from a refill kit package. 2. Firmly attach the two-way stopcock to the refill syringe and attach an 18 gauge needle to the stopcock. Label the syringe IN2. 3. Draw 20 mL of INSULIN (two vials) into the IN2 syringe. 4. Remove the 18 gauge needle and expel all air bubbles in the syringe. 5. Close the stopcock. 6. Retract the plunger until it locks into place.
Dmp9196021-011_c.book Page 86 Wednesday, April 3, 2002 5:04 PM 86 15. Press the refill syringe into the Pump fill port, open the stopcock and allow the Pump vacuum to draw INSULIN into the reservoir until the fluid level stops moving. Close the stopcock. 16. Remove the IN2 syringe and prepare for aspiration without expelling any fluid. Obtain a vacuum by pulling back on the plunger until it locks. Press the lock into the plunger groove to be sure it is firmly secured. 17.
Dmp9196021-011_c.book Page 87 Wednesday, April 3, 2002 5:04 PM 87 time the priming bolus was initiated on the implant worksheet. If you have removed the plastic tubing WARNING placed on the Pump outlet, DO NOT TRY TO REPLACE THE TUBING BACK ON THE PUMP OUTLET. You can displace or damage the “O” ring placed around the outlet. To measure the stroke volume, you need to use the procedure described in Appendix G, after the Catheter has been attached. ! 3.
Dmp9196021-011_c.book Page 88 Wednesday, April 3, 2002 5:04 PM 88 Prepare the Side Port Catheter The Side Port Catheter (“Catheter”) is attached to the Pump before implantation; however, it must be primed with INSULIN and inspected before being attached to the Pump. WARNING ! Never insert a needle into the connector end of the Catheter for priming or for testing. there may be a precision sealing surface in the connector that will be damaged by the insertion of any needle. 1.
Dmp9196021-011_c.book Page 89 Wednesday, April 3, 2002 5:04 PM 89 Figure 9: Rotate Tubing Retainer Figure 9-2: Pull Tubing Retainer off Pump.
Dmp9196021-011_c.book Page 90 Wednesday, April 3, 2002 5:04 PM 90 Figure 9-3: Tubing and Retainer Removed. Step 4 Inspect the outlet of the Pump for debris. Debris, especially fibers, left in the fluid path will compromise the function of the Catheter check valve. Rinse the outlet tube of the Pump with water from a syringe, if necessary. Avoid wiping the Pump with gauze or drapes that will leave fibrous debris. WARNING ! Step 5 Use caution when removing debris from the outlet of the Pump.
Dmp9196021-011_c.book Page 91 Wednesday, April 3, 2002 5:04 PM 91 Step 6 Only after the Catheter is seated, squeeze the connector, 1, firmly against the Pump between the thumb and forefinger of one hand. Then push the locking bar, 2, into place with the thumb of the other hand.
Dmp9196021-011_c.book Page 92 Wednesday, April 3, 2002 5:04 PM 92 Step 7 Verify the Catheter is securely attached to the Pump. Look into the connector and observe the position of the locking bar with respect to the Pump connector outlet. Check the side port connector hub for abnormalities (e.g., cracks, misalignment.) Step 8 Using the IN2 refill syringe, enter the Catheter side port cone and push a small amount of INSULIN out the Catheter tip.
Dmp9196021-011_c.book Page 93 Wednesday, April 3, 2002 5:04 PM 93 Performing the surgical procedure Pre-operative evaluation The Pump implant depth should not exceed 5 cm (2 inches) beneath the surface of the skin. If the Pump is implanted too deeply in the subcutaneous tissue it may be difficult to access the refill port. Formation of the pump pocket Pump implantation can be performed either under local or general anesthesia.
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Dmp9196021-011_c.book Page 95 Wednesday, April 3, 2002 5:04 PM 95 Catheter placement The Catheter is not designed to be tunneled subcutaneously. The Catheter insertion should be at the extreme edges of the Pump pocket. At a site not directly beneath the Pump, the layers of abdominal musculature are divided to expose the peritoneum. Concentric purse string sutures are placed and the peritoneum is exposed with a 1 cm incision. The distal tip of the Catheter is placed in the peritoneal space.
Dmp9196021-011_c.book Page 96 Wednesday, April 3, 2002 5:04 PM 96 stabilize. During post-operative hospitalization, the Pump can be reprogrammed to accommodate the needs of the patient. As post-operative stress decreases, insulin requirements may decline. It may be necessary to make several changes in insulin delivery rates during the first few days following implantation. Patients must be thoroughly educated in all aspects of follow-up care with the Pump.
Dmp9196021-011_c.book Page 97 Wednesday, April 3, 2002 5:04 PM 97 CHAPTER 5 Pump Refill Procedure Introduction Initial appointments for Pump Refills should be made with patients at the time of implantation. Subsequent appointments should be made in advance, normally during each refill procedure. The Pump stores approximately 6,000 units of insulin medication and typically requires a refill every two to three months.
Dmp9196021-011_c.book Page 98 Wednesday, April 3, 2002 5:04 PM 98 Pump Refill Procedure Supplies and solutions The refill kit (MMT-4105) is intended exclusively for use with the Medtronic MiniMed 2007C Implantable Insulin Pump System. The refill kit consists of a specially designed syringe and stopcock for removing fluids from and placing fluids into the Pump. Use only refill needles (MMT4102) available from MiniMed to perform all Pump refill procedures.
Dmp9196021-011_c.book Page 99 Wednesday, April 3, 2002 5:04 PM Introduction Prepare for pump refill NOTE: Before beginning any refill, rinse, flush, or pressure measurement procedure, carefully read Appendix D, Precautions and General Procedures. WARNING ! Never push on the refill syringe plunger to fill the Pump. When the refill needle is properly seated in the Pump fill port, the vacuum in the Pump reservoir will draw the insulin from the syringe into the reservoir.
Dmp9196021-011_c.book Page 100 Wednesday, April 3, 2002 5:04 PM 100 Pump Refill Procedure Perform the refill procedure Fill out the refill form Fill out the top part of the Refill Form (Appendix C) with the patient’s I.D., refill date, insulin lot number, previous refill volumes, insulin medication remaining, and the name of the person performing the refill procedure. This information can be helpful for diagnostic purposes.
Dmp9196021-011_c.book Page 101 Wednesday, April 3, 2002 5:04 PM Perform the refill procedure Prepare the refill syringe for filling the Pump 1. Firmly attach the stopcock to the IN refill syringe and attach an 18 gauge needle to the stopcock. Draw 20 ml of Aventis HOE PH U-400 insulin into the syringe. 2. Expel all air from the refill syringe. Close the stopcock and remove the 18 gauge needle. 3. Retract the plunger until it locks into place.
Dmp9196021-011_c.book Page 102 Wednesday, April 3, 2002 5:04 PM 102 Pump Refill Procedure Empty the Pump 1. Obtain a vacuum in the RB syringe by pulling back on the plunger until it locks. Press the lock into the plunger groove and be sure it is firmly secured. 2. Locate the fill port by centering the template over the Pump. The cen- ter hole in the template should be directly over the Pump fill port. Insert the 18 gauge guide needle into the Pump fill port.
Dmp9196021-011_c.book Page 103 Wednesday, April 3, 2002 5:04 PM Perform the refill procedure Step3B Step3A 18G Guide Needle 2mm Refill Needle Septum Spring Valve Filter Step 3A: Locate the port using the 18Ga guide needle slide the refill needle down the guide needle. Step 3B: Pull back approxiamately 2mm on the guide needle to enter the Pump. Step 3C: Apply firm pressure to move the valve back and allow the insulin to pass above the valve through the filter and into the reservoir.
Dmp9196021-011_c.book Page 104 Wednesday, April 3, 2002 5:04 PM 104 Pump Refill Procedure Refill the Pump 1. Use the IN refill syringe containing 20 ml of degassed insulin. 2. Enter the Pump by passing the refill needle with the attached IN refill syringe through the 18 gauge guide needle. Pull back slightly (approximately 2 mm) on the 18 gauge needle to allow the refill needle to enter the Pump and actuate the inlet valve (see Figure 13). 3. Open the stopcock.
Dmp9196021-011_c.book Page 105 Wednesday, April 3, 2002 5:04 PM Perform the refill procedure OPTIONAL Use this step only if the plunger is not moving during the fill of the reservoir. With the refill needle pointing down, vent the syringe head space by pulling back firmly on the plunge until the second sealing ring on the black rubber cap passes beyond the vent hole (see Figure 14). Figure 14: Venting the MiniMed Refill Syringe 5. Remove the IN syringe.
Dmp9196021-011_c.book Page 106 Wednesday, April 3, 2002 5:04 PM 106 Pump Refill Procedure Calculate extracted and refill amounts 1. Calculate the extracted amount by using the calculation section of the refill form. 2. Calculate the refill amount by using the calculation section of the refill form. 3. Enter the extracted amount (amount withdrawn as calculated on the refill worksheet at line E) and the refill amount (as calculated on the refill worksheet at line G) into the PPC (see Chapter 3).
Dmp9196021-011_c.book Page 107 Wednesday, April 3, 2002 5:04 PM 107 CHAPTER 6 Explanting the Pump System Explant considerations When the battery in the Pump is depleted or if acceptable glycemic control cannot be achieved, it may become necessary to explant the Pump system. Prior to explantation, it may be possible to perform interventions that could correct certain conditions. These procedures are described in Appendices E and F.
Dmp9196021-011_c.book Page 108 Wednesday, April 3, 2002 5:04 PM 108 Explanting the Pump System Be certain to include required patient information as well as the RMA number, date, and reason for the explant and place all pertinent documentation in a water tight document package. Put the RMA number on the shipping label. Please take the necessary precautions when shipping the Pump System via commercial carrier to avoid damage to the Pump. Please return explanted Pump Systems to: United States: MiniMed Inc.
Dmp9196021-011_c.book Page 109 Wednesday, April 3, 2002 5:04 PM 109 CHAPTER 7 Warnings And Precautions Warnings The Physician should be completely familiar with the function of the Pump, Catheter, and PPC prior to use. Patients should be provided a complete copy of the Patient Manual and have demonstrated the ability to program the PPC, recognize and respond to safety alarms, and take care of the device prior to discharge.
Dmp9196021-011_c.book Page 110 Wednesday, April 3, 2002 5:04 PM 110 Warnings And Precautions to test Pump function (e.g., program a bolus and then cancel the bolus) after such procedures, to determine that the Pump and PPC are operating properly. If the system is not performing correctly, contact MiniMed. Diagnostic ultrasound The Medtronic MiniMed 2007C Implantable Insulin Pump System has been tested during diagnostic ultrasound procedures. These procedures have no effect on Pump performance.
Dmp9196021-011_c.book Page 111 Wednesday, April 3, 2002 5:04 PM Warnings Elevated anti-insulin antibodies The result of clinical investigations suggest a small population of patients may develop anti-insulin antibodies when using the MiniMed 2007 Implantable Pump System and HOE 21 PH U-400 insulin. Patients with multiple autoimmune disorders may be more susceptible to developing high titers of anti-insulin antibodies, which in turn may cause symptoms.
Dmp9196021-011_c.book Page 112 Wednesday, April 3, 2002 5:04 PM 112 Warnings And Precautions elevations above 8,000 feet or 2,400 meters should not use the Pump. Patients who use the Pump and who plan to travel to an elevation above 2,400 meters (8,000 feet) should first have their Pump reservoir emptied of insulin, and they must self-administer insulin by other means for the duration of the trip and until their Pump reservoir is refilled again.
Dmp9196021-011_c.book Page 113 Wednesday, April 3, 2002 5:04 PM Precautions NOTE: Do Not Re-Sterilize the Implantable Insulin Pump NOTE: Do Not Re-Sterilize the Side Port Catheter NOTE: Do Not Re-Sterilize Components of the Refill Kit. The Pipette (MMT -4104), may be resterilized using autoclave or EtO. The Template MMT-4106 may be resterilized using steam autoclave or EtO. This template is made from polycarbonate plastic and will have a limited life in steam autoclave cycle.
Dmp9196021-011_c.book Page 114 Wednesday, April 3, 2002 5:04 PM 114 Warnings And Precautions electronics. If either situation occurs, contact MiniMed immediately and arrange for the repair or replacement of the PPC. If the PPC is accidentally splashed, sprayed or immersed, remove excess moisture with a soft towel and then place the PPC in a warm place to thoroughly dry. When dry, perform a “SELF TEST.” If the PPC does not display correctly, call MiniMed to replace the device.
Dmp9196021-011_c.book Page 115 Wednesday, April 3, 2002 5:04 PM 115 CHAPTER 8 Adverse Reactions Adverse reactions In clinical studies, adverse reactions associated with the Medtronic MiniMed 2007C Implantable Pump included hypoglycemia, diabetic ketoacidosis, hyperglycemia, skin erosion, infection, abnormal healing, elevated anti-insulin antibodies, intestinal obstruction, post-operative discomfort and pain, and corrective surgery for Pump and Catheter malfunctions.
Dmp9196021-011_c.book Page 116 Wednesday, April 3, 2002 5:04 PM 116 Adverse Reactions Prevention The majority of adverse reactions in patients using the Medtronic MiniMed 2007C Implantable Pump System can be prevented by teaching patients dependable blood glucose monitoring. The patient plays a significant role in diagnosing and correcting Pump System performance problems. Should Pump performance change, the patient would be able to detect a change in blood glucose levels.
