BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 100, 48 PACK,50125

    MDR report key: 1973261 · Received January 28, 2011

    Report

    Report Number
    6000001-2011-00518
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 3, 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: THE ROOT CAUSE OF THE "RUPTURED RESERVOIR" WILL BE IDENTIFIED/ADDRESSED THROUGH THE CAPA INVESTIGATION, IDC-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PER THE CUSTOMER'S INITIAL REPORT, THE DEVICE IS AVAILABLE FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO RETRIEVE THE SAMPLE AND ADDITIONAL INFORMATION. BAXTER WILL CONTINUE TO ATTEMPT TO RETRIEVE ADDITIONAL INFORMATION AS WELL AS THE SAMPLE. 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/NARRATIVE: PER THE CUSTOMER, THE DEVICE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION; THEREFORE, THE REPORTED CONDITION OF 'RESERVOIR RUPTURED' COULD NOT BE CONFIRMED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE 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 HAD RUPTURED DURING FILLING. ACCORDING TO THE REPORT, THE DEVICE WAS BEING FILLED WITH SODIUM CHLORIDE. ROUGHLY 60ML OF SODIUM CHLORIDE WAS FILLED WHEN THE RUPTURE 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 10K070

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE