BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 2142117 · Received May 26, 2011

    Report

    Report Number
    2026095-2011-00147
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 4, 2011
    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

    METHOD: SAMPLE HAS NOT YET BEEN REC'D, BUT WAS REPORTED TO BE AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. INFO PROVIDED INDICATES THE PUMP WAS UNDERFILLED TO 96ML, WHICH DOES FLOW FASTER THAN A NOMINALLY FILLED PUMP. THE DIRECTIONS FOR USE (1303046 REV. H) CONTAINS A CAUTION STATEMENT: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN REC'D AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5FU 2400MG/ML. FILL VOLUME: 96ML & FLOW RATE: 2ML/HR. PROCEDURE: UNK. CATHPLACE: UNK. DID NOT INFUSE, THEN RAN FAST. NURSE NOTED ON SECOND DAY THAT THE PUMP WAS NOT INFUSING. THE PUMP WAS MANIPULATED AND THEN STARTED INFUSING. THEN THE PUMP WAS EMPTY IN 24 HOURS. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2011. PER DFU: NOMINAL FLOW RATE: 2ML/HR. NOMINAL FILL VOLUME: 100ML. MAXIMUM FILL VOLUME: 125ML. THE INFUSION DELIVERY TIME IS 48 HOURS (2 DAYS) WHEN FILLED TO NOMINAL VOLUME AND FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP ELASTOMERIC PUMP MEB I-FLOW CORP. 04434370 LT 100-48 082258

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR