BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3790020 · Received May 5, 2014

    Report

    Report Number
    1416980-2014-14447
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED BETWEEN JULY 17, 2013 AND JULY 18, 2013 . EVALUATION: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL INSPECTION NOTED A RUPTURED BLADDER. DURING MICROSCOPIC EXAMINATION MARKINGS LOCATED ON THE EXTERIOR SURFACE OF THE BLADDER WERE OBSERVED NEAR THE RUPTURE LINE. THE CAUSE OF THE RUPTURE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A SMALL VOLUME INTERMATE RUPTURED. THIS OCCURRED DURING FILLING WITH CEFTAZIDIME SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269348 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 13G019

    Patients

    Seq Age Sex Outcome Treatment
    1