BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300 INTRA-AORTIC PUMP

    MDR report key: 4106592 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00145
    Event Type
    Injury
    Date Received
    March 28, 2014
    Date of Event
    February 12, 2014
    Report Date
    February 12, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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 FOUND THAT THE DRIVE TRANSDUCER WAS SMEARED WITH VACUUM GREASE AND CAUSED THE EVENT REPORTED. PROCEEDED TO REPLACE THE DRIVE MANIFOLD ASSEMBLY (PART # 01104-00-0018). FUNCTIONAL AND SAFETY CHECKS WERE PERFORMED TO MEET THE FACTORY SPECIFICATIONS. THE PUMP WAS RETURNED TO THE CUSTOMER. THE DRIVE MANIFOLD ASSEMBLY IS BEING RETURNED TO THE MANUFACTURING FACILITY IN MAHWAH, NJ FOR EVALUATION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PATIENT, THE IABP GENERATED "ELECTRICAL ERROR CODE # 58". (ELECTRICAL CODE #58 = POWER-UP VENT FAILURE). THE CUSTOMER TURNED THE UNIT OFF AND ON AND THE ALARM WAS GENERATED AGAIN. THE IABP BOOTED NORMALLY DURING THE THIRD TIME. THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185350 CS300 INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other