BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2000595 · Received February 2, 2011

    Report

    Report Number
    9616066-2011-00031
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    October 26, 2010
    Report Date
    November 2, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 02/02/2011. (B)(4). THE PRIMARY SET WAS RECEIVED FOR INVESTIGATION AND A CHECK VALVE FAILURE WAS CONFIRMED THROUGH FUNCTIONAL TESTING. THE CHECK VALVE SUPPLIER IDENTIFIED A CLEAR PARTICLE, IDENTIFIED TO BE PVC, LOCATED BETWEEN THE HOUSING SEAL AREA AND THE AFFIXED SILICONE DIAPHRAGM. THE CAUSE OF THE CHECK VALVE FAILURE IS THE PARTICLE PREVENTING THE SILICONE DIAPHRAGM FROM FULLY SEATING AGAINST THE HOUSING SEAL AREA. THE SOURCE OF THE PARTICLE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SECONDARY BAG OF SODIUM PHOSPHATE INFUSED FASTER THAN INTENDED. THE 107 ML BAG WAS TO INFUSE OVER 6 HOURS (APPROXIMATELY 17 ML/HR). AFTER 1 HOUR THE BAG WAS EMPTY BUT THE PUMP SHOWED A VTBI OF 98 ML. THERE WAS NO PATIENT HARM. CUSTOMER'S TESTING SHOWED A HIGH LEVEL OF PHOSPHATE IN THE PRIMARY BAG FLUID, WHICH SHOULD HAVE HAD NONE, INDICATING A LIKELY CHECK VALVE FAILURE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| NON-ALARIS SECONDARY SET