BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3900344 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20653
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION IS ANTICIPATED AND UPON COMPLETION OF THE INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION DRAINED OF FLUID AND WITH A BROKEN SYRINGE TIP INSIDE THE FILL PORT. VISUAL INSPECTION SHOWED NO DEFECTS. FLOW OF FLUID WAS OBSERVED FROM THE DISTAL LUER AFTER THE DEVICE WAS FILLED WITH WATER. THE REPORTED PROBLEM WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LARGE VOLUME INFUSOR EXPERIENCED NO FLOW AFTER AN UNKNOWN DRUG WAS INJECTED INTO THE FILL PORT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376849 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION 12C052

    Patients

    Seq Age Sex Outcome Treatment
    1