BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3961662 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24478
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED JANUARY 10, 2014 TO JANUARY 13, 2014. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION WITH APPROXIMATELY 100 ML OF FLUID IN ITS BLADDER. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED BY REMOVING THE LUER CAP FROM THE UNIT¿S DISTAL LUER. AFTER CAP REMOVAL, FLOW WAS VISUALLY OBSERVED AND CONTINUED TO FLOW WITHOUT STOPPING. NO NONCONFORMANCES WERE OBSERVED DURING EVALUATION. 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 SMALL VOLUME INFUSOR EXPERIENCED A NO FLOW DURING FILLING. A FORCED PRIME WAS ATTEMPTED BUT WAS NOT SUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439429 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14A004

    Patients

    Seq Age Sex Outcome Treatment
    1