BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE LV167,24 PACK

    MDR report key: 2020821 · Received March 16, 2011

    Report

    Report Number
    6000001-2011-01903
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). BROKEN CONDITION NOT CONFIRMED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL ACCEPTANCE CRITERIA FOR RELEASE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER HEALTHCARE THAT ONE (1) CE INTERMATE LV167 DEVICE WAS OBSERVED WITH BROKEN TUBING. THIS WAS OBSERVED BEFORE USE. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE LV167,24 PACK PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 10K106

    Patients

    Seq Age Sex Outcome Treatment
    1