BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23265230 · Received October 10, 2025

    Report

    Report Number
    2249723-2025-0004225
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 22, 2025
    Report Date
    January 10, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 FIELDS: B4, D9, G3, G6, H2, H6 (INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: G2. THE FSE INSPECTED THE UNIT AND REPLACED THE HELIUM RESORVIOR ASSEMBLY (D997-00-0565). THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS IN ACCORDANCE WITH THE MANUFACTURER'S SPECIFICATIONS. THE FOLLOWING INVESTIGATION WAS PERFORMED BY CARL FAMULARE, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ CF 06 NOV 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 ASSY, HELIUM RESERVOIR SERIAL NUMBER HR206810C WITH A REPORTED UNIT FAILURE OF FOUND HELIUM LEAK. 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. PERFORMED THE ALL MANIFOLD TEST. THE HELIUM RESERVOIR PASSED ALL TESTING. RETAINING THE HELIUM RESERVOIR IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Description of Event or Problem · 0

    IT WAS REPORTED BY GETINGE FSE THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD HELIUM LEAK DURING PM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112463 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown