BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4243382 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39889
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 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

    (B)(4). THIS LOT WAS MANUFACTURED FROM JULY 23, 2014-JULY 25, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION WHITE PARTICLES RANGING IN SIZE FROM 0.85 ¿ 1.79 MM WERE OBSERVED FLOATING IN THE FLUID WITHIN THE RESERVOIR. FOURIER TRANSFORM INFRARED SPECTROSCOPY DETERMINED THE PARTICLE TO BE POLYESTER MATERIAL. 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 PROBLEM IS UNKNOWN. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RESERVOIR OF A HALF DAY INFUSOR HAD PARTICULATE CONTAMINATION. THIS WAS NOTED AFTER COMPOUNDING WITH DESFERRIOXAMINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725146 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14G050

    Patients

    Seq Age Sex Outcome Treatment
    1