BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1701058 · Received May 24, 2010

    Report

    Report Number
    2016493-2010-00439
    Event Type
    Other
    Date Received
    May 24, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 16, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 5/24/2010. (B)(4). THE REPORTED EXPERIENCE OF PUMP FAILING RATE ACCURACY TEST COULD NOT BE CONFIRMED NOR REPLICATED; RATE ACCURACY CALIBRATION TEST PERFORMED AT THE MANUFACTURING FACILITY FOUND THE PUMP INFUSION WITHIN SPECIFICATIONS. HOWEVER, HIGH ACCUMULATION OF DRIED FLUIDS WAS FOUND UNDER THE MEMBRANE FRAME OF THE BEZEL AS WELL AS IN THE GROOVES OF THE BEZEL ASSEMBLY. THE POINT OF ENTRY FOR THE FLUID APPEARS TO BE THROUGH THE TOP AND SIDES OF THE MEMBRANE FRAME. THE CAUSE OF THE CUSTOMER'S EXPERIENCE OF DEVICE FAILING RATE ACCURACY TEST COULD NOT BE DETERMINED, HOWEVER, IT IS LIKELY THAT THE DRIED FLUID CONDITION CONTRIBUTED TO THE REPORTED ISSUE. THE BEZEL ASSEMBLY, BOTH PRESSURE SENSORS, MEMBRANE FRAME, PLATEN, MECHANISM ASSEMBLY, DOOR, DOOR COVER, DOOR HARNESS AND DOOR LATCH WERE REPLACED. THE DEVICE WAS RETURNED TO THE FACILITY AFTER PASSING ALL REQUIRED SERVICE LEVEL TESTING. THE DEVICE HISTORY RECORD WAS REVIEWED AT THE MANUFACTURING FACILITY, AND IT DID NOT SHOW ANY MANUFACTURING ISSUES DURING PRODUCTION BUILD FOR THE INVOLVED PUMP. THE SERVICE DATABASE AND PRODUCT PERFORMANCE MONITORING DATABASE REVIEW SHOWED NO PRIOR ISSUES OR ANOMALIES HAVE BEEN REPORTED AND INDICATED NO PRIOR SERVICE REPAIR HISTORY FOR THE SUSPECT INFUSION PUMP.

    Description of Event or Problem · 1

    CUSTOMER SENT DEVICE IN WITH REPORT OF FAILING RATE ACCURACY TEST AND STATED THERE WAS NO PT EVENT. DURING SERVICING RESIDUE WAS FOUND ON THE PUMP FINGERS AND OCCLUDERS.

    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