BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300 INTRA-AORTIC PUMP

    MDR report key: 4106593 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00144
    Event Type
    Injury
    Date Received
    March 28, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED THE EVENT WAS REVIEWED. DURING THE MANUFACTURING ON 2009, IT WAS NOTICED THAT SYSTEM WAS UNABLE TO CALIBRATE THE DRIVE TRANSDUCER AND IT WAS REPLACED. THE SYSTEM MET THE REQUIREMENTS AND IT WAS RELEASED. THE COMPANY REPRESENTATIVE NOTED THAT THE PURGE VALVE ASSEMBLY (0104-00-0026) TEST FAILED. IT WAS REPLACED AND PERFORMED COMPLETE CALIBRATIONS AND FUNCTIONAL CHECKS TO MEET FACTORY SPECIFICATIONS. THE UNIT WAS PLACED ON SERVICE AND WILL STAY ON MAHWAH SITE UNTIL IS NEEDED (UNIT USED FOR DEMONSTRATION AND FOR LOAN). THE PURGE VALVE ASSEMBLY WAS RETURNED AND IS UNDER EVALUATION BY THE MANUFACTURING FACILITY IN MAHWAH, NJ. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ONCE THE PART EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE SERVICE REPRESENTATIVE REPORTED THAT PRIOR TO USE ON A PATIENT, THE DEMO UNIT WAS SHOWING A MAINTENANCE ERROR #3. THE PUMP WAS REPLACED AND THE THERAPY WAS INITIATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185123 CS300 INTRA-AORTIC PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other