BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4891888 · Received July 6, 2015

    Report

    Report Number
    1416980-2015-27701
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 27, 2015
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED FLUID INSIDE THE HOUSING; HOWEVER, THE BLADDER WAS NOT FOUND TO BE RUPTURED. SIMULATED USE TESTING WAS PERFORMED BY MANUALLY FILING THE DEVICE WITH NORMAL SALINE. DURING FILL, THE SOLUTION WAS FOUND TO FLOW DIRECTLY INTO THE HOUSING. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE MISSING FILM-WRAP. A CAPA HAS BEEN OPENED TO ADDRESS THIS 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 LARGE VOLUME INFUSOR RUPTURED. THIS OCCURRED DURING FILLING WITH NORMAL SALINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435470 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 14N053

    Patients

    Seq Age Sex Outcome Treatment
    1