BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4140729 · Received October 3, 2014

    Report

    Report Number
    1416980-2014-34417
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 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 EXACT PATIENT AGE IS UNKNOWN; HOWEVER, IT IS KNOWN THAT THE PATIENT IS A CHILD. THE DEVICE WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LOT WAS MANUFACTURED BETWEEN MARCH 3, 2014 AND MARCH 4, 2014. EVALUATION SUMMARY: BAXTER RECEIVED THE UNIT FOR EVALUATION. VISUAL INSPECTION ON THE UNIT REVEALED NO EVIDENCE OF RUPTURE OF THE RESERVOIR. THE REPORTED CONDITION COULD NOT BE VERIFIED, THOUGH THE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION IN REGARDS TO AN UNRELATED ISSUE. 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 THE BLADDER OF A HALF DAY INFUSOR RUPTURED. THIS WAS NOTICED AFTER THE DEVICE WAS FILLED WITH 960 MG OF DESFERRIOXAMINE IN 52 ML OF 0.9% SODIUM CHLORIDE (BAXTER-COMPOUNDED SOLUTIONS). 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
    619931 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14C013

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE 0.9%| DESFERRIOXAMINE 960 MG