BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2944473 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02991
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING FLUID IN THE RESERVOIR. VISUAL EXAMINATION OF THE UNIT CONFIRMED THE REPORTED CONDITION OF A LEAK, OBSERVED AT THE CONNECTION OF THE BLUE WINGED LUER CAP, WHICH WAS NOT SECURELY TIGHTENED. AFTER THE CAP WAS SECURELY TIGHTENED, THE LEAKAGE COMPLETELY STOPPED. FUNCTIONAL TESTING OF THE DEVICE REVEALED NO SIGNS OF LEAK AFTER A 24-HOUR LEAK-MONITORING PERIOD. THE ROOT CAUSE WAS DETERMINED TO BE AN UNTIGHTENED WINGED LUER CAP. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. ADDITIONAL INFORMATION: 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 OF AN INFUSOR THAT LEAKED AFTER THE WINGED LUER CAP FELL OFF. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THIS POTENTIALLY CAUSED A BREACH IN THE STERILE FLUID PATHWAY OF THE DEVICE. 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
    49299 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12K076

    Patients

    Seq Age Sex Outcome Treatment
    1