BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 100, 48 PACK,50125

    MDR report key: 1973273 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00523
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 28, 2010
    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 NARRATIVE: PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION BY BAXTER. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE SAMPLE AND/OR ANY ADDITIONAL INFORMATION. BAXTER WILL CONTINUE TO ATTEMPT TO CONTACT THE CUSTOMER FOR THIS 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 NARRATIVE/INFORMATION: PER THE CUSTOMER, THE DEVICE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION; THEREFORE, THE REPORTED CONDITION OF "LEAKING" COULD NOT BE CONFIRMED. THE ROOT CAUSE IS UNKNOWN. SHOULD THE SAMPLE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. 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

    IT WAS REPORTED TO CORPORATE PRODUCT SURVEILLANCE (CPS) VIA EMAIL THAT ONE (1) CE INTERMATE SV 100 DEVICE WAS OBSERVED LEAKING AT AN UNKNOWN LOCATION DURING FILLING THE DEVICE WITH SODIUM CHLORIDE. 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 10K070

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE