BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2842949 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05787
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR LEAKED AFTER FILLING. THE DEVICE WAS FILLED WITH A SOLUTION OF 13.5MG TAZOCIN IN NORMAL SALINE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. 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 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12D033

    Patients

    Seq Age Sex Outcome Treatment
    1