BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 250, 24 PACK,50126

    MDR report key: 2061575 · Received April 18, 2011

    Report

    Report Number
    6000001-2011-02946
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED AND THE CONDITION FOUND DURING SERVICE WAS CONFIRMED. THE FILM WRAP WAS MISSING FROM THE DEVICE. THE ROOT CAUSE OF THE MISASSEMBLED CONDITION WAS DUE TO OPERATOR ERROR DURING THE FILM WRAP ASSEMBLY PROCESS. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING SAMPLE EVALUATION BY BAXTER FOR A SEPARATE REPORTED CONDITION (SEE REPORT 6000001-2011-02521), A MISSING FILM WRAP WAS DISCOVERED BY BAXTER'S SAMPLE TECHNICIAN. THIS REPRESENTS A POTENTIAL BREACH IN THE STERILE FLUID PATHWAY. THIS WAS NOT REPORTED BY THE CUSTOMER; RATHER DISCOVERED DURING SERVICE/TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 250, 24 PACK,50126 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10M013

    Patients

    Seq Age Sex Outcome Treatment
    1