BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 100, 48 PACK,50125

    MDR report key: 1973254 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00519
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 2011
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION BY BAXTER. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE SAMPLE AS WELL AS ADDITIONAL INFORMATION. BAXTER WILL CONTINUE TO ATTEMPT TO CALL THE CUSTOMER TO RETRIEVE THE SAMPLE AS WELL AS ADDITIONAL INFORMATION. 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). ADDITIONAL INFORMATION: PER THE CUSTOMER, THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF "BROKEN TUBING" COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT IS UNKNOWN. IN ADDITION, THE LOT NUMBER IS UNKNOWN, PER THE CUSTOMER, THEREFORE A BATCH REVIEW COULD NOT BE CONDUCTED. SHOULD THE SAMPLE AND/OR ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER HEALTHCARE THAT ONE (1) CE INTERMATE SV DEVICE WAS OBSERVED WITH THE END OF THE TUBING BROKEN OFF DURING FILLING. THE DEVICE WAS BEING FILLED WITH SODIUM CHLORIDE WHEN THIS OCCURRED. 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 100, 48 PACK,50125 PUMP, INFUSION FRN

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE