BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 6100372 · Received November 14, 2016

    Report

    Report Number
    1416980-2016-17278
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 14, 2016
    Manufacturer
    BAXTER HEALTHCARE- IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K011317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A VISUAL INSPECTION WAS PERFORMED AND THERE WERE NO SIGNS OF BLOCKAGE OR PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED FLOW PROBLEM. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND WAS FOUND TO BE WITHIN THE PRODUCT SPECIFICATION. THE REPORTED ISSUE 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 A NO FLOW EVENT. THE INFUSOR WAS FILLED WITH MORPHINE AND NACL 0.9%. IT WAS REPORTED THAT THE INFUSOR WAS STILL FULL AFTER THE EXPECTED INFUSION TIME. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752152 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE- IRVINE NA 16E063

    Patients

    Seq Age Sex Outcome Treatment
    1 MORPHINE| NACL 0.9%