BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3914371 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21591
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE LOT WAS MANUFACTURED FROM SEPTEMBER 13, 2011 TO SEPTEMBER 14, 2011. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION WITH 90 ML OF SOLUTION IN ITS BLADDER. VISUAL INSPECTION IDENTIFIED FLUID INSIDE OF THE STRESS MEMBER COLUMN THAT RESEMBLED AN AIR BUBBLE. THE VOLUME OF THIS FLUID WAS FOUND TO BE 1.3 ML. 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. THE CAUSE WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED LARGE VOLUME INFUSOR, AN INTERNAL LEAK OF SOLUTION INTO THE UNIT¿S STRESS MEMBER WAS IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390574 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11J032

    Patients

    Seq Age Sex Outcome Treatment
    1