BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SAF PUMP

    MDR report key: 1914307 · Received November 15, 2010

    Report

    Report Number
    2026095-2010-00279
    Event Type
    Other
    Date Received
    November 15, 2010
    Report Date
    October 18, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS REC'D FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. NO DETERMINATION CAN BE MADE AS TO WHY THE PUMP APPEARED TO INFUSE QUICKLY. THE DEVICE HISTORY RECORD FOR 052916, 032633 AND 082236 LOT WAS REVIEWED. ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPEC. IF ADDITIONAL INFO PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS REC'D, THE FILE WILL BE REOPENED.

    Description of Event or Problem · 1

    PUMPS EMPTIED TOO FAST. EXPECTED TO LAST 68 HOURS, BUT WERE EMPTY IN 30-36 HOURS. NO ADVERSE EVENT OCCURRED. NO PUMPS WERE EVALUATED BY OR RETURNED TO PHYSICIAN, BUT PTS WERE MADE AWARE OF WHAT THE PUMP APPEARANCE WOULD BE WHEN EMPTY. DATES OF OCCURRENCE: RECENTLY. OTHER POSSIBLE LOT NUMBERS ARE: 032633 AND 082236.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SAF PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. CB004 052916

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK