BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16065071 · Received December 28, 2022

    Report

    Report Number
    2249723-2022-03435
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    January 10, 2019
    Report Date
    December 27, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE COMPLAINT NUMBER: (B)(4). A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO EVALUATE THE IABP AND CONFIRMED THE BLOOD BACK OCCURRENCE. THE STM TRACED THE TRAIL BACK TO THE PRESSURE/VACUUM RESERVOIR AND REMOVED ALL BLOOD CONTAMINATED PARTS. THE STM INSTALLED A NEW DRIVE MANIFOLD INSULATOR (P/N: 0349-00-0301), CABLE CLAMP (P/N: 0343-05-0001), HOSE (P/N 0103-00-0642), RESERVOIR ASSEMBLY (P/N: 0202-00-0127), TUBING (P/N 0008-08-0001), LUER VALVE (P/N: 0103-00-0398-01), PURGE VALVE ASSEMBLY (P/N: 0104-00-0026), BLOOD DETECT TUBING (P/N: 0008-00-0312), CONDENSATE REMOVAL MODULE (P/N: 0997-00-0986-01), AND SAFETY DISK (P/N: 0997-00-0985-01) . THE STM THEN REASSEMBLED THE IABP UNIT AND COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP UNIT WAS RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED A BLOOD BACK EVENT AND BLOOD WAS SEEN IN THE SAFETY DISK. THERE WAS NO PATIENT HARM AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454515 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown