BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2230211 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21926
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE FILLED SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A RUPTURED RESERVOIR WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE BLADDER RUPTURED IN A FOOTED POSITION. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION OF THE BLADDER RUPTURE ISSUE IS IN PROGRESS THROUGH IDC-CAPA-(B)(4).

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INTERMATE HAD A RESERVOIR RUPTURE DURING FILLING. THE DEVICE WAS BEING FILLED WITH A 150-ML SOLUTION OF 6000 MG CEFTAZIDIM ANTIBIOTIC DRUG IN 0.9% SALINE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 11A038

    Patients

    Seq Age Sex Outcome Treatment
    1