BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3130115 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13378
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS VISUALLY INSPECTED AND WAS OBSERVED TO HAVE A RUPTURED BLADDER IN A NON-FOOTING POSITION. THE BLADDER WAS MICROSCOPICALLY EXAMINED AND WAS FOUND TO HAVE MARKINGS ON THE INTERIOR SURFACE OF THE BLADDER NEAR THE RUPTURE LINE, INDICATING INTERNAL DAMAGE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON OF A CE INTERMATE, SV 200 BURST DURING FILLING WITH TOBRAMYCIN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231878 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12N021

    Patients

    Seq Age Sex Outcome Treatment
    1