BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1790602 · Received August 2, 2010

    Report

    Report Number
    2016493-2010-00455
    Event Type
    Other
    Date Received
    August 2, 2010
    Date of Event
    April 1, 2010
    Report Date
    June 2, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 08/02/2010. (B)(4). THIS REPORT WAS FILED BY THE MFR. THE REPORTED CUSTOMER'S EXPERIENCE OF PUMP FAILING RATE ACCURACY TEST AND NOT BEING ABLE TO BE CALIBRATED WAS CONFIRMED AND REPLICATED. INSPECTION OF THE INTERNAL COMPONENTS SHOWED CONSIDERABLE WET FLUID, BROWN IN COLOR, OBSERVED ON THE PRINTED CIRCUIT BOARDS AND CONNECTORS THROUGHOUT THE DEVICE. EVIDENCE OF PREVIOUS FLUID INGRESS DAMAGE WAS ALSO OBSERVED ON THE BEZEL, SEVERAL OF THE BEZEL GROOVES AND ON THE SIDES OF THE BOTTOM (SECONDARY) PUMPING FINGER. THE FLUID RESIDUE WAS REMOVED FROM THE INTERNAL COMPONENTS AND THE PUMP WAS RETESTED AND FOUND TO BE INFUSING WITHIN SPECIFICATIONS. THE ROOT CAUSE OF THE RATE ACCURACY ISSUE WAS DUE TO THE DRIED FLUIDS DISCOVERED ON THE BEZEL ASSEMBLY AND PUMPING FINGER. THE DEVICE WAS REPAIRED AND SENT BACK TO THE CUSTOMER AFTER PASSING ALL SERVICE LEVEL TESTING.

    Description of Event or Problem · 1

    CUSTOMER SENT DEVICE IN WITH REPORT OF PUMP WOULD NOT PASS RATE ACCURACY TEST AND UNABLE TO BE CALIBRATED. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA