BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC PUMP

    MDR report key: 3905512 · Received May 28, 2014

    Report

    Report Number
    2249723-2014-00770
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    November 5, 2013
    Report Date
    November 5, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY REPRESENTATIVE WAS UNABLE TO DUPLICATE THE REPORTED EVENT. HE RAN A PERFORMANCE TEST WITH A SIMULATOR AND TEST BALLOON; RESULTS WERE SATISFACTORY. PERFORMED CONDENSATION REMOVAL PROCEDURE. PERFORMED SAFETY DISK LEAK TEST AND THE RESULTS WERE SATISFACTORY. PERFORMED CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECIFICATIONS. THE UNIT WAS RELEASED TO THE CUSTOMER. A SUPPLEMENTAL MEDWATCH REPORT 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 HAD A POSSIBLE LEAK AND CONDENSATION. 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
    315008 CS300 INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1