BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3250037 · Received July 26, 2013

    Report

    Report Number
    1416980-2013-19864
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RETURNED, HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS AVAILABLE FOR EVALUATION. INSPECTION OF THE PHOTOGRAPH REVEALED NO CLEAR EVIDENCE OF THE RUPTURED BLADDER. THE REPORTED CONDITION COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADDER OF AN INFUSOR RUPTURED. THIS OCCURRED BEFORE USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350865 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13A041

    Patients

    Seq Age Sex Outcome Treatment
    1