BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1233125 · Received November 18, 2008

    Report

    Report Number
    6000001-2007-06116
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    January 31, 2007
    Report Date
    April 4, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: THE REPORTED CONDITION OF THE INACCURACY WAS NOT DUPLICATED OR CONFIRMED. ACCURACY TESTS WERE PERFORMED AND ALL VALUES ARE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    BAXTER CUSTOMER SERVICE RECEIVED A FAX REPORTING THAT A FLO-GARD INFUSION PUMP WAS SET TO DELIVER AN UNKNOWN MEDICATION AT 12 ML/HR. THE PUMP DELIVERED 250 ML IN 2 HOURS. THE PUMP INDICATED THAT 228 ML WERE INFUSED. TOTAL VOLUME STATUS WAS 520 ML. THE FACILITY¿S NURSE REPORTED THAT THE PATIENT WAS ADMITTED TO THE FACILITY IN EARLY 2007. A PRIMARY INFUSION OF 250 CC OF D5 CONTAINING 25,000 UNITS OF HEPARIN IN A 250 CC BAG WAS HUNG ON THE NEXT DAY AT 0700. THE PUMP WAS PROGRAMMED TO FLOW AT 7 CC/HR. AT 0845, THE NURSE ENTERED THE PATIENT¿S ROOM AND FOUND THE BAG EMPTY. A LAB DRAW WAS ORDERED EVERY 2 HOURS FOR THE NEXT 12 HOURS. THE PATIENT¿S INITIAL PARTIAL THROMBOPLASTIN TIME (PTT) LEVELS AFTER THE OVERINFUSION WAS DISCOVERED WAS WELL OVER THE FACILITY¿S NORMAL HIGH VALUE. THE PATIENT¿S PTT LEVELS RETURNED TO NORMAL RANGE 12 HOURS LATER. THE NURSE STATED THAT THE PATIENT HAD NO BLEEDING AND NO INJURY OR MEDICAL INTERVENTION OCCURRED. THE NURSE ADDED THAT THE PUMP INDICATED THE CORRECT VOLUME OF MEDICATION THAT SHOULD HAVE BEEN DELIVERED IN THAT TIME PERIOD. THE PATIENT WAS LATER DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR CONTINU-FLO SOLUTION SET