BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 100, 48 PACK,50125

    MDR report key: 1973275 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00524
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    December 29, 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/INFORMATION: PER THE CUSTOMER THE DEVICE WILL NOT BE SENT TO BAXTER FOR EVALUATION; THEREFORE, THE REPORTED CONDITION OF "TUBING FELL OFF" COULD NOT BE CONFIRMED. IN ADDITION, THE CUSTOMER DID NOT KNOW THE LOT NUMBER, THEREFORE A BATCH REVIEW COULD NOT BE CONDUCTED AS WELL. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: 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). ADDITIONAL NARRATIVE: PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION BY BAXTER. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO RETRIEVE THE SAMPLE AND OBTAIN 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER THAT THE TUBING OF ONE (1) CE INTERMATE SV100 DEVICE "FELL OFF" AFTER 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

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE