BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3912253 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21432
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURED 05/30/2013 ¿ 05/31/2013. THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION AND A FUNCTIONAL LEAK TEST WERE COMPLETED. THE VISUAL INSPECTION AND LEAK TEST DID NOT REVEAL EVIDENCE OF A LEAK. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED. THE DEVICE WAS DISCOVERED WET IN A BELTBAG DURING PATIENT USE. THE REPORTER STATED THE INFUSOR WAS FILLED WITH PIPERACILLIN AND TAZOBACTAM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391233 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13E082

    Patients

    Seq Age Sex Outcome Treatment
    1 BELTBAG| TAZOCIN (PIPERACILLIN AND TAZOBACTAM)