BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3841354 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17451
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS DESCRIBED AS A CHILD. THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS MANUFACTURED FROM DECEMBER 19, 2013 ¿ DECEMBER 20, 2013. EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED NO SIGNS OF PHYSICAL ABNORMALITY THAT COULD HAVE CAUSED THE REPORTED CONDITION. A FUNCTIONAL FLOW RATE TEST WAS THEN PERFORMED, AND THE FLOW RATE WAS FOUND TO BE WITHIN THE SPECIFICATION RANGE OF THE PRODUCT. THE REPORTED CONDITION WAS UNABLE TO BE VERIFIED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. 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 UNDER INFUSED. THE DEVICE WAS FILLED WITH 1000 MG DESFERRIOXAMINE IN 52 ML OF 0.9% SODIUM CHLORIDE, STORED IN A REFRIGERATOR, REMOVED, AND CONNECTED TO THE HOME PATIENT (HP) 4 HOURS LATER, WITH THE FLOW RESTRICTOR TAPED DIRECTLY TO THE HP¿S SKIN. THE REPORTER STATED THAT THE DEVICE FLOWED BEFORE PATIENT CONNECTION. AFTER TEN HOURS OF INFUSION, IT WAS FOUND THAT LESS THAN 25% OF THE FILL VOLUME HAD INFUSED. THE DEVICE FLOWED ON REMOVAL FROM THE HP. THERE WAS NO REPORT OF 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
    318819 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13N050

    Patients

    Seq Age Sex Outcome Treatment
    1