BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG9

    MDR report key: 20683139 · Received November 14, 2024

    Report

    Report Number
    2249723-2024-0004676
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 24, 2024
    Report Date
    March 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G1, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED HELIUM RESERVOIR (D997-00-0565) TESTED. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER AND CLEARED FOR USE. PART NUMBER 0997-00-1178 PNEUMATIC MODULE ASSY SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF PIM PHYSICALLY BROKEN. PART NUMBER 0997-00-0565 ASSY, HELIUM RESERVOIR SERIAL NUMBER (B)(6) WAS RECEIVED WITH THE REPORTED UNIT FAILURE OF THE HELIUM RESERVOIR FAILING THE HELIUM REGULATOR CALIBRATION. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND OBSERVED THAT PART NUMBER 0997-00-1178 PNEUMATIC MODULE ASSY SERIAL NUMBER (B)(6) WAS PHYSICALLY BROKEN. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION OF PART NUMBER 0997-00-0565 ASSY, HELIUM RESERVOIR SERIAL NUMBER (B)(6) AND FOUND THAT THE SCREW IN THE PORT OF THE CHECK VALVE WAS BROKEN OFF INTO THE PORT. DUE TO THE DAMAGE TO THE CHECK VALVE PORT THE FAT CANNOT INVESTIGATE THIS COMPLAINT ANY FURTHER. BECAUSE WE DON¿T KNOW HOW THE CHECK VALVE WAS DAMAGED AND HOW THE PIM WAS PHYSICALLY BROKEN, ROOT CAUSE WILL BE IMPOSSIBLE TO DEFINE. RETAINING THE PARTS IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AS. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT FAILED HELIUM REGULATOR CALIBRATION AND FILL MANIFOLD TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2232210 CARDIOSAVE HYBRID, TYPE B PLUG9 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown