BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4212159 · Received October 29, 2014

    Report

    Report Number
    1416980-2014-37966
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    October 6, 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). EVALUATION SUMMARY: THE SAMPLE WAS NOT RETURNED; HOWEVER, A PHOTOGRAPH WAS PROVIDED FOR EVALUATION. DURING PHOTOGRAPHIC INSPECTION, THE RESERVOIR WAS OBSERVED TO BE RUPTURED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE CAUSE OF THE RUPTURE IS UNKNOWN. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A PHOTOGRAPH OF THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR HAD A RUPTURED RESERVOIR. THE DEVICE HAD BEEN FILLED WITH FLUOROURACIL. THIS WAS NOTED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691587 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13M043

    Patients

    Seq Age Sex Outcome Treatment
    1