BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVAC 572

    MDR report key: 1407888 · Received June 24, 2009

    Report

    Report Number
    2016493-2009-00074
    Event Type
    Injury
    Date Received
    June 24, 2009
    Date of Event
    April 8, 2009
    Report Date
    June 4, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K894037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, THE SERIAL NUMBER WAS PROVIDED. THE PUMP WAS SENT TO THE HOSPITAL BIOMED DEPT. WHERE IT WAS REPAIRED, TESTED, AND PUT BACK INTO SERVICE. THE DEVICE HISTORY RECORD AND SERVICE DATABASE FOR THE SUSPECT PUMPING MODULE, WERE REVIEWED AT THE MFG FACILITY AND THEY DID NOT SHOW ANY MFG ISSUES OR ANOMALIES RESEMBLING THIS FAILURE. THE CUSTOMER SUPPLIED A COPY OF THEIR REPAIR RECORDS FOR THE DEVICE DOCUMENTING THE FAILURE DESCRIPTION, THE REPAIR ACTIVITY, AND INDICATING THE DEVICE PASSED ALL TESTS AFTER REPAIRS WERE MADE. THE PUMP WAS FOUND TO HAVE A DEFECTIVE PRESSURE TRANSDUCER. THE PRESSURE TRANSDUCER GEL IN THE HOUSING WAS CHEMICALLY DAMAGED FROM PROBABLE CLEANING AGENTS. THE PUMP IS NOT DESIGNED TO DETECT INFILTRATIONS AND IN THE DIRECTIONS FOR USE MANUAL IT IS STATED "THE PUMP, ITSELF, IS NOT DESIGNED OR INTENDED TO DETECT INFILTRATIONS AND WILL NOT ALARM IN MOST INFILTRATION CONDITIONS."

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PT'S ARM BECAME EXTREMELY SWOLLEN WHILE BEING INFUSED 0.9% NORMAL SALINE PLUS 5% DEXTROSE WITH 10MMOL POTASSIUM CHLORIDE AT 38 MLS PER HOUR VIA AN IVAC 572 INFUSION PUMP. THE LEFT ARM WAS COLD AND SWOLLEN FROM FINGER TIPS TO THE SHOULDER. THE PUMP WAS FOUND TO BE DISPLAYING "PRESSURE", BUT NOT ALARMING. THE INFUSION WAS STOPPED AND THE INTRAVENOUS CANNULA REMOVED. THE PT WAS THEN ASSESSED BY A DOCTOR AND INTRASITE GEL APPLIED TO THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVAC 572 FRN CARDINAL HEALTH ALARIS PRODUCTS IVAC 572 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Required Intervention