BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 16057804 · Received December 27, 2022

    Report

    Report Number
    2249723-2022-03320
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    January 11, 2021
    Report Date
    March 28, 2022
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THIS UNIT. THE FSE REPLACED ALL BLOOD CONTAMINATED PARTS (0104-00-0026, 0008-00-0312, 0997-00-0986-01, 0103-00-0398-01, 0997-00-0985-01 AND 0008-00-0377). THE FSE COMPLETED ALL SAFETY, FUNCTIONALITY AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA 584165.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A BLOOD BACK ISSUE. BLOOD IN UNIT DETECTED. CUSTOMER CAN SEE THE DRIED BLOOD IN THE DRAIN PORT TUBING. THE BALLOON RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050724 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 BALLOON CATHETER.