BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INTERMATE SV 50, 48 PACK, 50125

    MDR report key: 1994110 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01096
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K910425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE UNFILLED UNIT WAS RECEIVED BY BAXTER FOR EVALUATION. VISUAL EXAMINATION OF THE UNIT CONFIRMED THE BLUE WINGED LUER CAP MISSING NO OTHER OBSERVATION WAS FOUND ON THE UNITS. THE ROOT CAUSE WAS DUE TO OPERATOR ERROR DURING THE MANUAL WINGED LUER CAP ASSEMBLY PROCESS. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED ONE (1) CE INTERMATE SV 50 DEVICE FROM A (B)(6) CUSTOMER WITHOUT RECEIVING A VERBAL COMPLAINT REPORT FROM THEM. ACCORDING TO THE BAXTER MANUFACTURING FACILITY, THE DEVICE DID NOT CONTAIN THE BLUE WINGED CAP. THERE IS NO REPORT OF PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT WILL ADDRESS INCIDENT 11 OF 13.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INTERMATE SV 50, 48 PACK, 50125 PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE 09G008

    Patients

    Seq Age Sex Outcome Treatment
    1