BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 7718622 · Received July 25, 2018

    Report

    Report Number
    1416980-2018-04612
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    June 28, 2018
    Report Date
    July 25, 2018
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS MANUFACTURED AUGUST 16, 2017 - AUGUST 17, 2017. THE DEVICE WAS RECEIVED FOR EVALUATION CONTAINING APPROXIMATELY 40ML OF FLUID IN THE RESERVOIR. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS PERFORMED AND THE FLOW RATE WAS FOUND TO BE WITHIN THE PRODUCT SPECIFICATION RANGE. THE REPORTED CONDITION WAS NOT VERIFIED. 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 WOULD NOT FLOW. THE EVENT OCCURRED DURING PATIENT INFUSION WITH 2700MG DESFERRIOXAMINE (WITH A TOTAL SOLUTION OF 42ML). THE EXPECTED INFUSION TIME WAS TEN HOURS; HOWEVER, AFTER SEVEN HOURS ¿NOTHING HAD INFUSED¿. THE PATIENT THEN DISCONNECTED THE DEVICE. 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
    562056 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE NA 17H039

    Patients

    Seq Age Sex Outcome Treatment
    1 DESFERRIOXAMINE