BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16060246 · Received December 28, 2022

    Report

    Report Number
    2249723-2022-03347
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    July 18, 2019
    Report Date
    December 21, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE AUTHORIZED DEALER'S FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND REPLACED THE SAFETY DISK (0997-00-0985-01), THE CONDENSATE REMOVAL MODULE (0997-00-0986-01), THE TUBING ASSEMBLY, BLOOD DETECT (0008-00-0312), THE PURGE VALVE ASSEMBLY (0104-00-0026), AND THE TUBING CLEAR POLYURETHANE, 1/16¿ I.D (0008-08-0001) THAT WERE CONTAMINATED WITH BLOOD. THE FSE THEN PERFORMED ALL CALIBRATION, FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. 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) UNIT HAD BLOOD DRAWN BACK INTO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105880 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 79 YR Female UNKNOWN.