BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 17686041 · Received September 5, 2023

    Report

    Report Number
    2249723-2023-03908
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 25, 2023
    Report Date
    April 25, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONTACT NUMBER: (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) STATED VACUUM WAS TOO HIGH (-158). TO FIX THE ISSUE, THE FSE REPLACED COMPRESSOR AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED AND CLEARED FOR CLINICAL SERVICE THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART HYDR CMPNT PUMP ASSY DC KNF WITH A REPORTED UNIT FAILURE OF AUTOFILL TEST FAILED. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THAT THE TUBING THAT PROTECTS THE INNER WIRES WAS CUT, AND THE INNER WIRE SHEATHING WAS COMPROMISED WITH THE WIRE BEING EXPOSED. THIS DAMAGE POSES A RISK TO PERSONNEL AND TO THE TEST FIXTURE. DUE TO THIS DAMAGE AND THE RISK IT POSES, THIS PART CANNOT BE INVESTIGATED ANY FURTHER BY THE FAT DEPT. RETAINING THE PUMP IN THE FAT DEPT. PER PROCEDURE. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT AUTOFILL TEST FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974369 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 NA Unknown