BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERMATE

    MDR report key: 2842967 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05789
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 28, 2012
    Report Date
    October 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 100ML OF SOLUTION IN THE RESERVOIR. THE REPORTED CONDITION OF NO FLOW/NON-DELIVERY WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE DEVICE SHOWED NO SIGNS OF BLOCKAGE IN THE DELIVERY TUBING OR IN THE BLADDER THAT COULD HAVE CAUSED THE REPORTED CONDITION. WHEN THE SLIDE CLAMP WAS REMOVED, FLOW CONTINUED WITHOUT STOPPING. NO SIGNS OF FLOW PROBLEM WERE OBSERVED FROM THE SAMPLE DURING THE FUNCTIONAL TEST. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. 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 NO FLOW DURING PRIMING. THE DEVICE HAD BEEN FILLED WITH A SOLUTION CONTAINING 2000 MG MEROPENEM IN 100 ML 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 12H039

    Patients

    Seq Age Sex Outcome Treatment
    1