BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4100016 · Received September 18, 2014

    Report

    Report Number
    1416980-2014-32068
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED MARCH 3, 2014 ¿ MARCH 4, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED A WHITE ELONGATED PARTICLE, APPROXIMATELY 2.90 MM IN LENGTH, FLOATING IN THE FLUID OF THE RESERVOIR. FOURIER TRANSFORM INFRARED SPECTROSCOPY DETERMINED THAT THE PARTICLE WAS SILICONE RUBBER. THE CAUSE OF THE PARTICULATE MATTER IS UNKNOWN. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HALF DAY INFUSOR HAD A LARGE WHITE PARTICLE FLOATING IN THE FLUID OF ITS BLADDER. THIS WAS FOUND AFTER FILLING THE DEVICE WITH DEFEROXAMINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577765 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14C013

    Patients

    Seq Age Sex Outcome Treatment
    1