Summary of MedSun Reports Describing Adverse Events With Infusion Pumps in Pediatric Patients and Related Articles
MedSun: Newsletter #29, October 2008

By Elizabeth Eydelman, Patient Safety Staff, 2008

Over the past year and a half, MedSun has received 19 adverse event reports involving infusion pump problems which occurred in the pediatric or neonatal units of each respective hospital filing the report. These reports are associated with four manufacturers: Smiths Medical (11), Baxter Healthcare Corporation (3), Abbot Laboratories, Inc. / Hospira Global Medical Affairs (3), and Alaris Medical Systems, Inc. (2). The reports were submitted by 12 hospitals between January 1st 2007 and May 12th, 2008. The most frequently reported device problems are:

• Over infusion (6)
• Incorrect programming calculations/Design or structure problem (4)
• Cessation of pumping with an error message or dislodgement of component (3)
• Under infusion (2)
• Screen won’t advance in drug library due to small patient size (1)
• Battery failure (1)
• Failure to infuse (1)
• Self-activation (1)
• Failure to alarm (1)

There are no MedSun reports involving a patient death during this time period. There are 9 reports that do not list the type of adverse event, 7 reports that list event type as malfunction, and 3 reports list the adverse event type as injury. Of the reports that list patient problems, the most frequently reported patient problems are:

• Overdose (6)
• Under dose (5)
• Need for additional therapy or surgical treatment (3)
• Skin discoloration (2)

Of the reports that list patient gender, 11 reports involve female patients and 8 reports involve male patients. These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.

An article from the American Journal of Health-System Pharmacy, posted on MedScape online 9/7/0, entitled, Using Failure Mode and Effects Analysis to Plan Implementation of Smart I.V. Pump Technology, stresses the need for multi-disciplinary communication and training so that end users consistently use the pump features and respond to dosing alerts to reprogram erroneous pump programming. A safety tip by Julia Marders, RN, MS, posted on FDA/CDRH’s Medical Device Safety Website posted 4/1/2005, Sounding the Alarm for I.V. Infiltration, advises users to make check if the IV pump is designed for pediatric or adult patients prior to use and to follow the manufacturer's recommendations for the appropriate patient population when setting the pressure for infusion and downstream occlusion to avoid infiltration.

[Note: The reports have been edited for clarity]



MedSun Infusion Pump Adverse Event Reports received between January 1st 2007 and May 12th 2008
Device Device Identifiers Event Description
Smiths Medical/Infusion Pump Model: 3500 NURSE TRYING TO INITIATE MORPHINE INFUSION ON NEW OR PATIENT. UNABLE TO ADVANCE SCREEN IN PED CARDIO/THORACIC UNIT (PCTU) DUE TO FACT PATIENT WAS LESS THAN 50KG. REFERENCED # 1 LIBRARY ANALGESICS/SEDATIVES. ALSO, WON'T ADVANCE SCREENS IN OTHER LIBRARIES. UPON FURTHER INVESTIGATION, IT WAS ALSO FOUND THAT THE BATTERIES WERE DEPLETED DUE TO OVER HEATING AND UPON TESTING EXPRESSED APPROXIMATELY 25% LESS THAN ITS ORIGINAL CAPACITY.
Smiths Medical/Infusion Pump Model: 3500 PUMP WAS PLUGGED IN AND RUNNING WITH EPINEPHRINE RUNNING AT 0.1MCG/KG/MIN (VERY HIGH DOSE TO SUPPORT BLOOD PRESSURE) WHEN IT GAVE A HIGH PITCHED TONE. THE PUMP STOPPED RUNNING. THE DISPLAY READ "1 BIOMED". THE PUMP WAS CHANGED WITHOUT INCIDENT BUT IT COULD HAVE BEEN A DISASTER.
Baxter Healthcare Corporation/Infusion Pump Model: 2M8163 DURING TRANSPORT, BAXTER THREE CHANNEL IV PUMP FAILED. PT WAS ON TWO DRIPS, MOST IMPORTANTLY, MAGNESIUM SULFATE. IV WAS CHANGED TO A SECOND PUMP AND THE REST OF THE TRIP WAS UNEVENTFUL.
Smiths Medical/Infusion Pump Model: 2001 HEPARIN INFUSION VIA PUMP. SHOULD HAVE DELIVERED 6 ML PER READING ON PUMP. SYRINGE STILL FULL AT 48.5 ML. NO VOLUME DELIVERED TO PATIENT ACCORDING TO SYRINGE LEVEL. PROBLEM IDENTIFIED BECAUSE PATIENT WAS ON ECMO AND HAVING REGULAR ACTIVATING CLOTTING TIMES DONE. CLOTTING TIME DECREASED FROM 202 TO 184 TO 155 IN 1 HOUR. PUMP SENT TO SMITHS MEDICAL FOR EVALUATION AND REPAIR. COMPANY FOUND THAT CLUTCH SPRING WAS BROKEN CAUSING THE TACK TO MOVE FREELY WITHOUT PRESSING THE CLUTCH. THIS WAS CAUSING THE PUMP TO COUNT EVEN THOUGH INFUSION WAS NOT HAPPENING.
Smiths Medical/Infusion Pump Model: 2HC07A VANCOMYCIN SYRINGE WAS PLACED ON PUMP. THE PUMP WAS PROGRAMMED TO RUN OVER A TWO HOUR PERIOD. THE NURSE WENT TO CONNECT THE LINE TO THE PATIENT AND NOTICED THAT HALF THE MEDICATION WAS ALREADY INFUSED PRIOR TO CONNECTING TO THE PATIENT. THE PUMP WAS SET AT 22 ML/HR AND THERE HAD BEEN A TOTAL OF 44 ML IN THE SYRINGE. THE PATIENT DID NOT RECEIVE ANY OF THE FIRST HALF OF THE MEDICATION. THE PUMP WAS STOPPED AND THE SYRINGE WAS REMOVED. THE PUMP WAS SENT TO THE BIOMEDICAL DEPARTMENT WHERE THEY FOUND NOTHING WRONG WITH THE PUMP.
Smiths Medical/Infusion Pump Model: 3500 MEDICATION ERROR. DECIMAL BUTTON NOT PRESSED. EQUIPMENT DOES NOT ASK FOR A CONFIRMATION. THE PUMP WAS NOT SEQUESTERED. THE EQUIPMENT'S END OF LIFE IS 2011, AND IS NOT CURRENTLY SOLD. THE PT HAD NO VISIBLE EFFECTS NOTED.
Smiths Medical/Infusion Pump Model: 2001 AT 1930 AN INFUSION PUMP ON INFANT IN NICU STOPPED INFUSING AND ALARMED "INFUSION COMPLETE." THE INFUSION WAS LIPIDS; WHICH WAS TO BE INFUSING AT 1CC/HR FOR A TOTAL OF 21 HOURS. THE INFUSION WAS STARTED AT 1800 DURING THE PRIOR SHIFT. THE PUMP ALARMED AND REPORTED THERE WAS ONLY 7CC LEFT IN THE SYRINGE, WHICH MEANT 14 CC WERE INFUSED IN 1.5 HOURS. TWO RNS EVALUATED THE SYRINGE AND VERIFIED IT ONLY CONTAINED 7CC IN IT. NO LEAKS OR WETNESS WERE NOTED SO INFUSION WAS STOPPED AND NNP (NEONATAL NURSE PRACTITIONER) WAS NOTIFIED IMMEDIATELY. THE PATIENT HAD LAB WORK DUE SO IT WAS DONE AND REVIEWED WITH NO ADVERSE OUTCOMES OR INJURY NOTED. THE NNP ORDERED NO FURTHER LIPIDS UNTIL THE NEXT DAY AND BOTH NNP AND NURSING WILL MONITOR THE INFANT CLOSELY. THE PUMP WAS REMOVED FROM SERVICE AND CLINICAL ENGINEERING WAS NOTIFIED TO PICK UP
PUMP FOR EVALUATION.
Baxter Healthcare Corporation/Infusion Pump Catalog: 1M8550 WHILE IN THE INTENSIVE CARE NURSERY THE NURSE SET THE IV PUMP FOR 1CC/HR WITH A VOLUME LIMIT SET FOR 25CC. THE SYRINGE CONTAINED 60CC OF D10W WITH CALCIUM GLUCONATE. THE FLUIDS WERE STARTED AT 15:30. AT 16:00 THE SYRINGE PUMP WAS ALARMING INFUSION COMPLETE. WHEN NURSE CHECKED THE SYRINGE THERE WAS 0CC LEFT IN THE SYRINGE. THE IV PUMP SETTING WAS CHECKED WITH A SECOND NURSE. THE IV PUMP WAS SET CORRECTLY AT 1CC/HR WITH A VOLUME LIMIT OF 25CC. THE PUMP WAS READING 60CC INFUSED OVER 30 MINUTES. PUMP REMOVED FROM THE UNIT.
Smiths Medical/Infusion Pump Model: 3500 THE PATIENT WAS AN ACTIVE TODDLER RECEIVING MILRINONE AT A RATE OF 0.5 MCG/KG. THE PATIENT'S MOM LEFT THE ROOM, THE NURSE WENT TO CHECK ON THE PATIENT AND FOUND THAT THE SYRINGE OF MILRINONE HAD BEEN REMOVED FROM THE PUMP BY THE PATIENT AND WAS IN HIS HAND. THE NURSE VERIFIED AND CONFIRMED THAT NO EXTRA MEDICATION HAD BEEN DELIVERED. THIS PUMP DOES NOT LOCK, INSTEAD THE SYRINGE IS CLAMPED INTO THE PUMP. TO AVOID THIS FROM HAPPENING AGAIN, IT WOULD BE HELPFUL IF THERE WAS A LOCKING DEVICE ATTACHMENT AVAILABLE THAT COULD BE AFFIXED TO THE PUMPS FOR USE IN THE PEDIATRIC POPULATION.
Abbot Laboratories, Inc. / Hospira Global Medical Affairs/Infusion Pump Model: 12391-04-04 NURSE PROGRAMMED INFUSION PUMP AT 21 ML/HOUR INSTEAD OF 6.9 ML
Alaris Medical Systems, Inc./Infusion Pump Model: 8015, 8100 A NEW IV HAD BEEN STARTED AT 1900 HOURS ON THE LEFT ARM. THE ARM WAS CHECKED BY STAFF AT 2000, 2100, AND 2200 HOURS WITH THE SITE BEING NOTED AS CLEAR. AT THE 2300 HOURS THERE WAS A DISCOLORATION UNDER THE TAPE ON THE LEFT ARM WHICH RESULTED IN FOUR MARKS. THE IV WAS DISCONTINUED AND THE PUMP REMOVED FROM THE PATIENT AND BIOMED NOTIFIED. PHARMACY WAS ALSO CALLED TO CHECK ON THE CALCULATIONS AND SOLUTION AND VERIFIED THAT IT WAS ACCURATE. THE PUMP HAD DELIVERED IN 12 HOURS, WHAT SHOULD HAVE TAKEN 24 HOURS. THE PUMP WITH MODULES WERE SENT TO THE MANUFACTURER FOR ANALYSIS AND THE FACILITY IS WAITING FOR A RESPONSE.
Alaris Medical Systems, Inc./Infusion Pumps Model: 8015, 8100 THE BAG OF TPN WAS CHECKED AND ONLY 2.5 HOURS WERE LEFT TO DELIVER. THE BAG OF TPN SHOULD HAVE LASTED FOR 24 HOURS. BIOMED WAS NOTIFIED AND SECURED THE PUMP. PHARMACY WAS ALSO NOTIFIED TO REVIEW THE TPN CALCULATIONS AND CONFIRMED THE SOLUTION WAS ACCURATE. THE PUMP WITH MODULES WERE SENT TO THE MANUFACTURER FOR EVALUATION AND ARE AWAITING AN OFFICIAL RESPONSE.
Abbot Laboratories, Inc. / Hospira Global Medical Affairs/ Infusion Pump Device Identifiers Unknown/Not Available WHILE USING AN ABBOTT PLUM A PUMP, THE IV WAS FOUND TO BE INFILTRATED WITH BLISTER FLUID DURING THE ASSESSMENT. THE IV SITE WAS VERY SWOLLEN AND THE TOP OF THE FOOT WAS BLANCHED AND MEASURED 10CM AROUND THE FOOT. THE SECURITY BAND WAS ALSO ON THIS FOOT AND WAS FOUND TO BE VERY TIGHT ABOVE AND BELOW THE BAND. THE IV AND THE SECURITY BAND WERE REMOVED, AND THE FOOT WAS ELEVATED. A PLASTIC SURGERY CONSULTATION WAS CONDUCTED TWO WEEKS LATER, WHICH REVEALED THAT AFTER THE SCAB FALLS OFF, THERE SHOULD BE NO RESIDUAL EFFECTS DUE TO THE INFILTRATION. NO ALARMS SOUNDED DURING THIS EVENT.
Baxter Healthcare Corporation/Infusion Pump Model AS50 PROSTAGLANDINS INFUSING VIA BAXTER PUMP. PUMP STOPPED, WHEN RN WENT TO RESTART PUMP, GREEN START KEY WAS DISLODGED.
Abbot Laboratories, Inc. / Hospira Global Medical Affairs/Infusion Pump Model: 5000 NOTED THAT 30 CC OF LIPIDS SYRINGE WAS EMPTY. RATE ON INFUSION PUMP CHECKED AND WAS CORRECT. CHARGE NURSE NOTIFIED, AND WAS DETERMINED TO ORDER ANOTHER 30 CC SYRINGE FROM PHARMACY AND CONNECT TO INFUSION PUMP. INFUSING AT ORDERED RATE OF 0.7 CC/HR. APPROXIMATELY 5 HOURS LATER, SECOND SYRINGE OF LIPIDS WAS FOUND TO BE INFUSED. THE PHYSICIAN WAS NOTIFIED. PUMP AND TUBING REMOVED AND KEPT FOR INSPECTION. THE TPN AND THE LIPID INFUSION RATE HAD BEEN CROSSED. THE LIPIDS WERE RUNNING AT THE FASTER RATE AND THE BABY RECEIVED TOO MUCH LIPIDS. LABS DRAWN AND X-RAYS WERE TAKEN. BABY ON VENTILATOR -SETTINGS ARE 15/4, RATE OF 60, 40-60 FIXED OX. SETTINGS REMAIN UNCHANGED FROM EARLIER IN THE DAY. PHYSICIAN NOTIFIED OF LAB RESULTS. BLOOD ORDERED FOR EXCHANGE TRANSFUSION. OUR IV TUBING (#11374 50 ML BURETTE) HAD BEEN PLACED ON BACKORDER BY HOSPIRA AND WE WERE USING A SUBSTITUTE THAT HAD INSTRUCTIONS POSTED ON HOW TO PUT IT TOGETHER. THERE WAS NOT ANY AVAILABLE TUBING EXACTLY LIKE THE ONE WE USUALLY USE. THE HOSPIRA REP HAD BEEN INTO THE UNIT DAILY TO SEE IF THE BACK UP SYSTEM WAS WORKING AND IF WE NEEDED TO CHANGE THINGS. WE WERE HAVING DIFFICULTY USING A 3-PIECE SYSTEM BECAUSE THE STAFF WAS HAVING PROBLEMS GETTING ALL OF THE AIR OUT OF THE LINE. BABY HAD NOT EXPERIENCED ANY LASTING COMPLICATIONS AT THIS POINT AND IS CONTINUED TO BE MONITORED.
Smiths Medical/Infusion Pumps Model: 3500 SYRINGE INFUSION PUMP STOPPED AND BEEPED "CHECK CLUTCH." SYRINGE PUMP TAGGED WITH INFO AND PLACED IN SOILED ROOM. NEW SYRINGE PUMP USED.
Smiths Medical/Infusion Pump Model: Medfusion 2001 PATIENT'S CONDITION INDICATED THAT THERE WAS A POSSIBLE UNDERINFUSION OF MEDICATION. DEVICE ALARMED SYSTEM ERROR. WHEN INSPECTED, SOME DAMAGE WAS NOTED. THE DEVICE HAD A LOOSE PLUNGER TRACK AND THERE WERE CRACKS AROUND THE SCREW HOLES OF THE SLIDE HOUSING CAUSING UNDERINFUSION.
Smiths Medical/Infusion Pump Model: 2010 POSSIBLE UNDERINFUSION OF IV MEDICATION INDICATED BY PATIENT RESPONSE TO DRUG BEING INFUSED. INFUSION PUMP WAS PROGRAMMED TO DELIVER BODY WEIGHT/CONCENTRATION MODE WHICH IS USED BY ANESTHESIA. NURSING USES VOLUME OVER TIME AND RATE MODE, CAUSING CONFUSION TO NURSE OPERATOR AND POSSIBLY INDUCED PROGRAMMING ERROR.
Smiths Medical/Infusion Pump Model: 2010 UNDER INFUSION OF MEDICATION. THE PUMP HAD ALARMED FOR THE "CHECK CLUTCH" SENSOR. PUMP WAS RESET AND THE SYRINGE MARKED FOR VOLUME MEASUREMENT. TWO HOURS LATER, ANOTHER "CHECK CLUTCH" ALARM WAS NOTED AND NO VOLUME HAD INFUSED SINCE THE LAST ALARM.


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