BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 3002877 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06068
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A RUPTURED RESERVOIR WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE BLADDER RUPTURED IN A NON-FOOTED POSITION. THE ROOT CAUSE COULD NOT BE DETERMINED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INTERMATE HAD A RESERVOIR RUPTURE AT THE END OF FILLING. THE DEVICE WAS BEING FILLED WITH AN ANTIBIOTIC SOLUTION. 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
    105913 INTERMATE PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 12H067

    Patients

    Seq Age Sex Outcome Treatment
    1