BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22368937 · Received July 1, 2025

    Report

    Report Number
    2249723-2025-0002792
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 17, 2025
    Report Date
    September 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D9, G1(CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11. THE FOLLOWING INVESTIGATION WAS PERFORMED BY CARL FAMULARE, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 ASSY, HELIUM RESERVOIR SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF FAILING THE FILL MANIFOLD LEAK TEST. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0997-00-0565 ASSY, HELIUM RESERVOIR SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE HELIUM RESERVOIR TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT DEPT. COULD NOT CONFIRM THE COMPLAINT OF THE HELIUM RESERVOIR FAILING THE LEAK TEST. AFTER AN ALL-MANIFOLD TEST WAS PERFORMED, THE HELIUM RESERVOIR PASSED ALL TESTING. RETAINING THE HELIUM RESERVOIR IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AU. A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED THE FILL MANIFOLD ASSEMBLY (D997-00-0565) TO RESOLVE THE ISSUE. UNIT NOW PASSES LEAKAGE TEST. ISSUE RESOLVED. UNIT NOW PASSES ALL TESTS AND CALIBRATIONS TO MANUFACTURER STANDARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PM, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED FILL MANIFOLD LEAK TEST.THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215844 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown