BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4163485 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35360
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). (B)(6). THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FEBRUARY 10, 2014 ¿ FEBRUARY 11, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION WITH APPROXIMATELY 10 ML OF FLUID WITHIN ITS BLADDER. THE DEVICE¿S LABEL INDICATED THAT THE DEVICE HAD BEEN FILLED WITH DESFERRIOXAMINE. NO FLOW WAS OBSERVED WHEN THE DISTAL LUER CAP WAS REMOVED. MICROSCOPIC INSPECTION OF THE FLOW RESTRICTOR REVEALED CRYSTALLIZED DRUG BLOCKING THE FLUID PATH AT THE DISTAL END OF THE GLASS CAPILLARY. THE CAUSE OF THE NO FLOW CONDITION WAS DETERMINED TO BE THE CRYSTALLIZED DRUG BLOCKING THE FLUID PATHWAY IN THE FLOW RESTRICTOR. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SINGLE DAY INFUSOR DID NOT FLOW. IT WAS NOT SPECIFIED WHEN IN THE PROCESS THIS OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640518 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14B014

    Patients

    Seq Age Sex Outcome Treatment
    1