BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 200, 48 PACK,50125

    MDR report key: 1973442 · Received January 30, 2011

    Report

    Report Number
    6000001-2011-00532
    Event Type
    Malfunction
    Date Received
    January 30, 2011
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    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). ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: DURING THE EVALUATION OF THIS SAMPLE, A MISSING FILM WRAP WAS OBSERVED/CONFIRMED BY THE BAXTER SAMPLE TECHNICIAN. THIS WAS NOT REPORTED BY THE CUSTOMER. THE MISSING FILM WRAP WAS DUE TO AN OPERATOR ERROR DURING THE FILM WRAPPING ASSEMBLY PROCESS. 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. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    DURING THE SAMPLE EVALUATION/TESTING OF ONE (1) CE INTERMATE SV 200 DEVICE, THE SAMPLE TECHNICIAN OBSERVED/CONFIRMED A MISSING FILM WRAP. THIS WAS OBSERVED DURING TESTING OF THE SAMPLE BY BAXTER; THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE SV 200, 48 PACK,50125 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10C028

    Patients

    Seq Age Sex Outcome Treatment
    1