BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    MDR report key: 1240199 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-06188
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    April 11, 2007
    Report Date
    April 11, 2007
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK MANAGER STATED THAT AS FAR AS SHE KNEW THERE WAS NO INJURY OR MEDICAL INTERVENTION. THE RISK MANAGER STATED THAT THERE WAS NO CHANGE IN THE PATIENT'S VITALS. BAXTER SALES REP. VISITED THE SITE AND REPORTED THE SECONDARY TUBING WAS EMPTY AND THE PRIMARY TUBING WAS FULL WITH THE DRIP CHAMBER BEING COMPLETELY FULL PAST THE FILL LINE. THE 250 CC PRIMARY BAG WAS HUNG 30 MINUTES BEFORE THE SECONDARY WAS HUNG. NO ADDITIONAL INFORMATION IS AVAILABLE. EVALUATION RESULTS: THE REPORTED CONDITION OF THE OVERINFUSION WAS NOT DUPLICATED OR CONFIRMED. THE DEVICE PASSED ALL ACCURACY TESTING.

    Description of Event or Problem · 1

    THE FACILITY'S RISK MANAGER REPORTED THAT THE PATIENT WAS ADMITTED IN 2007 FOR RHABDOMYLYSIS. THE PATIENT FELL AT HOME AND WAS DISCOVERED ON THE FLOOR BY HER FAMILY HOURS LATER. AT ABOUT TEN DAYS LATER, A PRIMARY INFUSION OF 250 CC OF NORMAL SALINE (NS) WAS SET TO INFUSE 10 CC/HR. A 50 CC BAG CONTAINING 50 CC OF NS AND 25 MG OF DIAMOX WAS HUNG AT 0800 AT 100 CC/HR. THE SECONDARY TUBING WAS CONNECTED TO THE PRIMARY TUBING ABOVE THE PUMP. THE NURSE STARTED THE INFUSION, TURNED AROUND TO GET A MOUTH SWAB FOR THE PATIENT, AND NOTICED THAT THE BAG OF DIAMOX WAS EMPTY WHEN SHE TURNED BACK AROUND. THE RISK MANAGER STATED THAT THE PATIENT WAS "FINE," BUT THE NURSE THOUGHT THAT THE PATIENT HAD SOME REACTION TO THE DIAMOX BECAUSE SHE MADE URINE. PREVIOUSLY SHE WAS NOT MAKING A LOT OF URINE. THE RISK MANAGER DID NOT KNOW HOW MUCH URINE WAS PRODUCED BY THE PATIENT, BUT ADDED THAT THE PATIENT WAS RECEIVING THE DIAMOX FOR HEART FAILURE. THE RISK MANAGER STATED THAT NO LABS WERE ORDERED AS A RESULT OF THE REPORTED OVERINFUSION. CONTINUED IN H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6301 VOLUMETRIC INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 2C8537 - CONTINU-FLO SOLUTION SET.