BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 2043322 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00044
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    June 19, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIRECTIONS FOR USE (DFU) CONTAINS A CAUTION FOR UNDERFILLING THE PUMP: "CAUTIONS: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE." THE DEVICE HISTORY RECORD WAS CONDUCTED, AND ALL MFG OPERATIONS WERE FOUND TO MEET SPEC. A REVIEW OF THE LOT 792532 HISTORY FOUND THIS TO BE THE ONLY COMPLAINT OF FAST FLOW FOR THE LOT. I-FLOW RECEIVED ONE PARTIALLY FULL PUMP FOR EVAL AND INVESTIGATION. THE PINCH CLAMP WAS OPENED AND THE PUMP DID NOT INFUSE. THE PUMP WAS INJECTED WITH 7ML OF NORMAL SALINE WITH DYE ADDED TO CHECK FOR THE FLOW PATTERN. NO FLOW OCCURRED. THE TUBING WAS SEPARATED FROM THE PUMP AND THE FLOW CONTROL TUBING WAS PLACED IN WARM WATER WITH AN AIR SOURCE FOR ABOUT 8 HOURS FOR CLEANING. THE TUBING WAS REINSTALLED ON THE PUMP, AND THE PUMP DID INFUSE SLOWLY (133.80ML/HR INSTEAD OF 175ML/HR). THE BEST EVIDENCE SUGGESTS DRY MEDICATION IN THE TUBING RESTRICTED THE FLOW. CERTAIN DRUGS MAY PRECIPITATE DURING THE COURSE OF INFUSION WHICH MAY BLOCK THE FLUID PATHWAY. RETAIN SAMPLES FROM LOT 792532 WERE EVALUATED AND FOUND TO FLOW WITHIN SPEC. PRODUCT COMPLAINT IS NOT CONFIRMED FOR FAST FLOW.

    Description of Event or Problem · 1

    (DRUG/DILUENT: FORTUM 4GR/240ML). FAST FLOW: FILL VOLUME 240ML AND FLOW RATE 175ML/HR. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: UNK. PER DFU: NOMINAL FILL VOLUME: 250ML AND NOMINAL FLOW RATE: 175ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORP. ST 250-1.5 792532

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK