BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4010551 · Received August 14, 2014

    Report

    Report Number
    1416980-2014-26479
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Report Date
    July 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K062457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE WAS MANUFACTURED MAY 9, 2014 TO MAY 13, 2014. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED FLUID IN THE PACKAGING WHICH CONTAINED THE DEVICE. WHEN THE UNIT WAS REMOVED FROM THE PACKAGE, A LEAK WAS VISUALLY OBSERVED FROM THE UNTIGHTENED BLUE WINGED LUER CAP. A FUNCTIONAL LEAK TEST WAS SUBSEQUENTLY PERFORMED BY FILLING THE UNIT WITH WATER. AFTER FILL, THE BLUE WINGED LUER CAP WAS HAND TIGHTENED. THE NEXT DAY, NO SIGNS OF LEAK WERE OBSERVED AT THE BLUE WINGED LUER CAP. THE CAUSE OF THE LEAK WAS FOUND TO BE AN UNTIGHTENED BLUE WINGED LUER CAP. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION, AND NO NONCONFORMANCES WERE OBSERVED DURING EVALUATION. 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 THERE WAS A LEAK FROM THE CAP OF A HALF DAY INFUSOR. THE DEVICE HAD BEEN FILLED WITH 2000MG DESFERRIOXAMINE IN 40ML WATER FOR INJECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485667 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14E023

    Patients

    Seq Age Sex Outcome Treatment
    1