BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1587493 · Received January 20, 2010

    Report

    Report Number
    2016493-2010-00405
    Event Type
    Other
    Date Received
    January 20, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 15, 2009
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 01/20/2010. (B)(4). SERVICE LEVEL INVESTIGATION DETERMINED FLUID INGRESS CONTAMINATION AS THE CAUSE FOR THE REPORTED ALARM AND RESIDUE ON THE OCCLUDER FINGERS. THE MECHANISM SUBASSEMBLY, MEMBRANE FRAME, LEFT IUI CONNECTORS, UPPER AND LOWER PRESSURE SENSORS WERE REPLACED. THE DEVICE WAS RETURNED TO THE FACILITY AFTER PASSING ALL REQUIRED SERVICE LEVEL TESTING.

    Description of Event or Problem · 1

    CUSTOMER SENT DEVICE IN FOR REPAIR WITH REPORT OF 'CHECK IV SET' ALARM. SERVICE AT THE MANUFACTURING FACILITY INSPECTED THE DEVICE AND FOUND RESIDUE ON OCCLUDER FINGERS. CUSTOMER CONFIRMED THAT THERE WAS NO PT INCIDENT OR INFUSION INACCURACY REPORTED WITH THIS PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other