BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV 100, SINGLE-POUCH, 24 PACK

    MDR report key: 1932249 · Received December 17, 2010

    Report

    Report Number
    6000001-2010-05889
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: BAXTER RECEIVED A PHOTO OF THE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF "RUPTURED RESERVOIR" WAS CONFIRMED VIA PHOTOGRAPHIC EVALUATION. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM; THIS ISSUE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. 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 FRANCE THE RESERVOIR OF ONE (1) INTERMATE LV100 DEVICE HAD RUPTURED AFTER FILLING. ACCORDING TO THE REPORT, THE INTERMATE WAS FILLED WITH 70ML OF SODIUM CHLORIDE AND 40ML OF CEREZYME. THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV 100, SINGLE-POUCH, 24 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 09N024

    Patients

    Seq Age Sex Outcome Treatment
    1 CEREZYME| SODIUM CHLORIDE