BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3031017 · Received March 28, 2013

    Report

    Report Number
    2249723-2013-00030
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE PERFORMED AN EVALUATION OF THE IABP. HE DETERMINED THAT THE AUTOFILL FAILURE WAS CAUSED BY A CRACKED LUER FITTING (EXTERNAL DAMAGE TO THE IABP). HE REPLACED THE LUER FITTING. REGARDING THE ERROR CODE 54, THE COMPANY REPRESENTATIVE ADVISED THE CUSTOMER THAT THE SOLENOID DRIVER BOARD SHOULD BE REPLACED. AT THE TIME OF THIS REPORT, THE CUSTOMER HAD NOT ACCEPTED THE REPAIR. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED AN "AUTOFILL FAILURE". THEY ATTEMPTED A MANUAL FILL, AND THEN RECEIVED A CODE 54 (PROLONGED INFLATION FAILSAFE) MESSAGE MESSAGE. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129609 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI