BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1082558 · Received July 23, 2008

    Report

    Report Number
    2016493-2008-00100
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 1, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THIS REPORT WAS FILED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED A LOG REVIEW TO DETERMINE WHEN THE PUMPS WERE TURNED BACK ON AND IF THE INFUSIONS WERE REVERSED. REPORTED AT 9:00 AM, A PATIENT WAS TAKEN TO RADIOLOGY AND THE PUMPS WERE REMOVED FOR AN MRI. CUSTOMER STATES THAT INFUSIONS WERE NORMAL SALINE AND MORPHINE. THE LOG REVIEW SHOWS THAT ON (B) (6) 2008 AT 6:05 AM, PUMP A (B) (4) WAS INFUSING AT 1ML/HR AND PUMP B (B) (4) WAS INFUSING AT 125 ML/HR. DRUGS ARE NOT IDENTIFIED IN LOGS SINCE PUMPS PROGRAMMED AS BASIC INFUSIONS. AT 8:29 AM BOTH PUMPS ARE POWERED OFF. AT 8:59 AM THE PCU IS POWERED ON AND THE RESTORE FEATURE FOR PUMP A IS SELECTED: RESTORING A BASIC INFUSION OPTION, RATE 1ML/HR, VTBI 9.578. INFUSION RAN FOR 1 MINUTE AND PUMP IS POWERED OFF. PUMPS REMAINED OFF UNTIL 3:15PM. APPARENT UNDERINFUSION. AT 3:15 PM THE PCU IS POWERED ON. PUMP A IS PROGRAMMED FOR BASIC INFUSION, RATE 100ML/HR AND VTBI 900ML. PUMP B IS PROGRAMMED FOR BASIC INFUSION, RATE 1ML/HR AND VTBI 300ML. APPARENT OVERINFUSION. AT 3:55 PM THE RATES FOR BOTH LVPS ARE CHANGED: PUMP A CHANGED FROM 100ML/HR TO 1 ML/HR; PUMP B FROM 1ML/HR TO 125ML/HR. AT 4:01 PM PUMP A IS POWERED OFF. CUSTOMER REPORTS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LVP (8100) (B) (4)| PCU (8000) (B) (4)