BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3903357 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20960
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 14B028 WAS MANUFACTURED FEBRUARY 14, 2014 ¿ FEBRUARY 15, 2014. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS NOT RETURNED; HOWEVER, A PHOTOGRAPH WAS PROVIDED FOR EVALUATION. DURING PHOTOGRAPHIC INSPECTION THE DEVICE WAS NOTED TO HAVE LEAKED. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR¿S ¿END HAD COME ADRIFT FROM THE LEAD.¿ THIS MALFUNCTION RESULTED IN THE DEVICE LEAKING SOLUTION CONTAINING CEFOXITIN INSIDE OF THE OVERPOUCH. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379840 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B028

    Patients

    Seq Age Sex Outcome Treatment
    1