BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 100, 48 PACK,50125

    MDR report key: 2020850 · Received March 16, 2011

    Report

    Report Number
    6000001-2011-01916
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    September 3, 2010
    Report Date
    February 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. 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 SAMPLE WILL NOT BE RETURNED TO BAXTER FOR EVALUATION. THEREFORE, THE REPORTED CONDITION OF 'MISSING BLUE WINGED CAP' COULD NOT BE CONFIRMED. SHOULD THE SAMPLE AND/OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) INTERMATE SV 100 WAS MISSING THE BLUE WINGED LUER CAP. THIS WAS OBSERVED BEFORE USE. 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 BAXTER HEALTHCARE - IRVINE 10E071

    Patients

    Seq Age Sex Outcome Treatment
    1