BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-IN-ONE TPN SOLUTION BAG

    MDR report key: 15167 · Received August 10, 1994

    Report

    Report Number
    MW1003052
    Event Type
    Malfunction
    Date Received
    August 10, 1994
    Report Date
    August 9, 1994
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BAXTER HEALTHCARE CORP. ROUTE 120 & WILSON RD, ROUND LAKE, IL 60073-0490. 1. FIRM'S EVALUATION. THE CUSTOMER REPORTED THE MEMBRANE SEAL (INJECTION PORT) HAD FALLEN OFF OF 5 BAGS, RESULTING IN LEAKAGE. SAMPLES WERE NOT RETURNED FOR OUR EVALUATION. A REVIEW OF THE PRODUCTION RECORDS DID NOT IDENTIFY ANY SIMILAR FINDINGS DURING THE MFG OF LOT P052159. NO SIMILAR REPORTS HAVE BEEN RECEIVED ON LOT P05219. 2. SEVERITY, FREQUENCY. THERE IS NO STATED SEVERITY OR FREQUENCY FOR THIS TYPE OF PROBLEM. NO INCREASE IN FREQUENCY HAS BEEN NOTED. 3. REMEDIAL ACTION. NO REMEDIAL ACTION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL-IN-ONE TPN SOLUTION BAG TPN SOLUTION BAG KPE BAXTER HEALTHCARE CORP. P052159

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other