BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2133170 · Received June 19, 2011

    Report

    Report Number
    6000001-2011-08053
    Event Type
    Malfunction
    Date Received
    June 19, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. UPON VISUAL INSPECTION THE REPORTED CONDITION WAS CONFIRMED. THE SAMPLE WAS MISSING THE TIP OF THE SPIKE. THE COMPONENT USED ON THIS CODE IS PURCHASED FROM AN EXTERNAL SUPPLIER. A SUPPLIER VISIT HAS ALREADY BEEN PERFORMED TO INVESTIGATE FURTHER THIS ISSUE AND A SUPPLIER CORRECTIVE ACTION REPORT HAS BEEN OPENED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT ON THE 23RD MAY A FLOGARD IV SOLUTION ADMINISTRATION SET WAS SPIKED IN AN UNKNOWN BAG WHEN THE SPIKE BECAME DETACHED FROM THE SET. THE SPIKE WAS STUCK IN THE BAG AND THEREFORE THE PATIENT DID NOT RECEIVE THEIR CHEMOTHERAPY TREATMENT THAT DAY. A PATIENT WAS INVOLVED, BUT NO INJURY WAS INCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS ADMINISTRATION, SET, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN BAG