BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLEAGUE TRIPLE CHANNEL PUMPCE DANISH/NORWEGIAN

    MDR report key: 1227394 · Received November 14, 2008

    Report

    Report Number
    6000001-2007-88829
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    April 8, 2007
    Report Date
    April 11, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON MAY 08, 2007. THE PUMP IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE LOCAL COMPLAINT COORDINATOR. BAXTER RECEIVED A REPORT FROM FACILITY, AN INCIDENT INVOLVING AN INFUSION PUMP, WHICH STOPPED DURING PATIENT INFUSION. INITIALLY IT WAS REPORTED THAT THE PATIENT'S RENAL FUNCTION STOPPED AS A RESULT. ADDITIONAL INFORMATION WAS PROVIDED BY THE FACILITY TO BAXTER IN 2007: ALL THREE CHANNELS WERE IN USE. CHANNEL A HAD NORADRENALINE INFUSING AT 20 ML/HR. THE RATE OF NORADRENALINE WAS INCREASED TO 45 ML/HR TO REACH NEEDED EFFECT. THE FACILITY REALIZED THE PUMP DID NOT DELIVER THE RIGHT VOLUME. THE NURSE SWITCHED TO ANOTHER PUMP AND THERE WERE NO FURTHER PROBLEMS. PATIENT IS A FEMALE WITH SEPSIS. SHE WAS SEDATED AND ON A RESPIRATOR. THE INFUSION WAS STARTED 2007 AT 1745. THE PUMP WAS SWITCHED FOR ANOTHER AT 0900 THE NEXT DAY. THE SET WAS LOADED CORRECTLY. A CENTRAL VENOUS CATHETER WAS USED. BP AT START WAS 70 (SYSTOLIC) AND AFTER SWITCHING TO ANOTHER PUMP IT WAS 110/50. THE DESIRED VOLUME OF THE PUMP WAS NOT DELIVERED AND LESS VOLUME WAS DELIVERED THAN WHAT WAS PROGRAMMED. THERE WAS NO UPSTREAM OCCLUSION. ADDITIONAL INFORMATION WAS PROVIDED ON THE FOLLOWING MONTH, BY THE LOCAL COMPLAINT COORDINATOR WHO STATED THAT THERE WAS NO INJURY TO THE PATIENT. SHE CONFIRMED THAT PUMP AS WELL AS THE SET UNDER-DELIVERED (FOR MALTA SET FLO-GARD IV SOLUTION ADMINISTRATION SET, WHICH IS NOT DISTRIBUTED IN THE U.S.). THE SERIAL NUMBER OF THE PUMP WAS NOT OBTAINED NOR WAS IT EVALUATED. CORRECTED DATA: ORIGINALLY IT WAS REPORTED THAT THE INFUSION STOPPED AND RESULTED IN PATIENT INJURY TO THE PATIENT'S RENAL STATUS, BUT THAT WAS NOT THE CASE.

    Description of Event or Problem · 1

    BAXTER RECEIVED A REPORT FROM A MEDICINES AGENCY, AXEL HEIDES GADE 1, DK-2300 KOBENHAVN S) AND INCIDENT INVOLVING AN INFUSION PUMP WHICH STOPPED DURING PATIENT INFUSION. REPORTEDLY, THE PATIENT'S RENAL FUNCTION STOPPED AS A RESULT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT'S DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING. NO ADDITIONAL CONTACT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE TRIPLE CHANNEL PUMPCE DANISH/NORWEGIAN 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening