BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMS GRASEBY

    MDR report key: 317128 · Received February 22, 2001

    Report

    Report Number
    1120886-2001-00001
    Event Type
    Other
    Date Received
    February 22, 2001
    Date of Event
    January 16, 2001
    Report Date
    February 22, 2001
    Manufacturer
    MARCAL MEDICAL/IMPORTER-DISTRIBUTOR, SIMS GRASEBY LTD.
    Product Code
    FRN
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PUMP INFUSED A CARDIAC STRESS AGENT 30 SECONDS TOO FAST DURING A CARDIAC STRESS TEST. MARCAL'S BIOMEDICAL SERVICE TECH TROUBLE SHOT OVER THE PHONE WITH HOSPITAL BIOMEDICAL SERVICE TECH, AND DETERMINED THAT THERE WAS NO DEATH OR INJURY TO THE PT INVOLVED. HE ALSO DETERMINED THAT THE CUSTOMER WAS USING A 30CC SYRINGE. HOWEVER, THE SYRINGE SIZE SENSOR DISPLAY ON THE PUMP WAS INDICATING THAT A 20CC SYRINGE WAS BEING USED. THE PUMP WOULD INDEED INFUSE INCORRECTLY IF THE SYRINGE SIZE DISPLAY READ DIFFERENTLY FROM THE ACTUAL SIZE OF THE SYRINGE BEING USED. THE OPERATIONS MANUAL CLEARLY PROHIBITS USING THE PUMP IF THE SYRINGE SIZE SENSOR DISPLAY READING DOES NOT AGREE WITH THE SYRINGE SIZE BEING USED. THIS WAS AN OBVIOUS OPERATOR ERROR AND COULD HAVE BEEN PREVENTED IF THE USER HAD READ THE DISPLAY BEFORE USING THE PUMP. CO REQUESTED THE PUMP BE RETURNED TO MARCAL MEDICAL FOR REPAIR AND CALIBRATION. AN INCIDENT REPORT WAS FILLED OUT TO BE FOLLOWED UP ON WHEN INVESTIGATION COMPLETED. INVESTIGATION IN PROGRESS REPORT TO FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6883 SIMS GRASEBY SYRINGE PUMP FRN MARCAL MEDICAL/IMPORTER-DISTRIBUTOR, SIMS GRASEBY LTD. 3400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other