BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE EDITION INFUSION PUMP

    MDR report key: 1438616 · Received August 7, 2009

    Report

    Report Number
    2016493-2009-00092
    Event Type
    Injury
    Date Received
    August 7, 2009
    Date of Event
    July 31, 2008
    Report Date
    July 10, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K070268
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PUBLICATION MONITORING PERFORMED OF CAREFUSION PRODUCTS BY CARDINAL HEALTH VIA THE INTERNET, AN ARTICLE WAS IDENTIFIED WITH THE FOLLOWING EVENT INFO: THE PT WAS HAVING A PROCEDURE THAT WOULD ELIMINATE CLOTS IN THE SMALLER ARTERIES OF HER LOWER FOOT WHEN SHE RECEIVED 25,000 UNITS OF HEPARIN IN 30 MINUTES. ABOUT THREE HOURS LATER, "THERE WAS OOZING BLOOD NOTED FROM THE SHEATH" FOLLOWED BY A DROP IN [SHAW'S] BLOOD PRESSURE, LOW HEMOGLOBIN AND ABDOMINAL DISTENSION SUGGESTING A BLEED, AS WELL AS RIGHT-SIDED INTRA-CEREBRAL BLEEDS. THE PT EXPERIENCED A RIGHT-SIDED STROKE THAT CAUSED PERMANENT MAJOR PHYSICAL AND NEUROLOGICAL INJURIES, INCLUDING LEFT-SIDED PARALYSIS/NEGLECT, GENERAL LETHARGY AND LOSS OF MEMORY AND COGNITIVE FUNCTION. THE ARTICLE IDENTIFIES AN ALARIS INFUSION PUMP INVOLVED IN THE OVER INFUSION OF HEPARIN. ACCORDING TO THE ARTICLE, THE LEGAL BRIEF STATES NURSES ATTEMPTED TO PROGRAM THE GUARDRAIL SYSTEM POSSIBLY 4 TIMES OR MORE, AND WERE NOT ABLE TO GET THE SYSTEM TO ACCEPT THEIR INPUT. THE NURSES CONTINUED EXITING AND RESTARTING THE PROGRAM OVERRIDING THE GUARDRAIL SAFETY FUNCTION TO GIVE THE PT THE DOSAGE THEY THOUGHT WAS 500 UNITS PER HOUR. THE FACILITY'S RISK MANAGER WAS CONTACTED AND OFFERED AN INVESTIGATION OF THE PUMP, EVENT LOG REVIEW AND FUNCTIONAL TESTING. CUSTOMER STATED THE DEVICE HAS BEEN REQUESTED SINCE THE EVENT AND DECLINED A MANUFACTURER DEVICE ANALYSIS. CUSTOMER INDICATED THEY HAVE CONDUCTED AN INTERNAL INVESTIGATION AND DETERMINED THAT THE CAUSE OF THE EVENT IS NOT A PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE EDITION INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 7100E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Disability