BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23413579 · Received October 29, 2025

    Report

    Report Number
    2249723-2025-0004470
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 1, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED SAFETY DISK THAT WAS FAILING THE MEMBRANE LEAK TEST. ALL FUNCTIONAL AND SAFETY TEST PASSED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9(RETURN TO MANUFACTURE), G3, G6, H2, H6 (HEALTH EFFECT ¿ CLINICAL CODE), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND REPLACED SAFETY DISK THAT WAS FAILING THE MEMBRANE LEAK TEST. ALL FUNCTIONAL AND SAFETY TEST PASSED. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0202-00-0140 REV K, SN: (B)(6). THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF ¿MEMBRANE LEAK TEST FAILED¿. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED A VISUAL INSPECTION, AND THE PART WAS FOUND TO BE IN GOOD PHYSICAL CONDITION WITH NO SIGNS OF MECHANICAL DAMAGE AND CONTAMINATION OBSERVED. INSTALLED SAFETY DISK INTO THE CARDIOSAVE TEST FIXTURE SN: (B)(6) AND TESTED TO THE FACTORY SPECIFICATIONS PER REVISION F AND THE CARDIOSAVE SERVICE MANUAL PN: 0070-00-0639 REVISION R. THE FAT DEPARTMENT PERFORMED STANDARD FUNCTIONAL TESTS AND PASSED. ALSO, THE FAT DEPT. PERFORMED ALL MANIFOLD TESTS. THE FAT DEPT. OBSERVED MEMBRANE LEAK TEST FAILED DURING ALL MANIFOLD TESTS WITH RESULT OF OUT OF FACTORY SPECIFICATION(-7MMHG). THE FAT DEPARTMENT REPLICATED FAILURE MESSAGE OF ¿MEMBRANE LEAK TEST FAILED¿. SAFETY DISK FAILED TESTING. RETAINING SAFETY DISK IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AU. THE CURRENT SAFETY DISK DESIGN ALLOWS FOR CREEP. FACTORS THAT MAY CONTRIBUTE TO CREEP INCLUDE: THE SPECIFIED TORQUE ON THE FASTENERS (6 BOLTS) IS APPLYING TOO MUCH STRESS ON THE DIAPHRAGM MEMBRANE. THE HELICAL WASHERS INSTALLED ALONG WITH THE 6 FASTENERS (BOLTS) ARE ENLARGING THE CREEP BY MAINTAINING STRESS ON THE DIAPHRAGM MEMBRANE AS IT DEFORMS. THE NON-UNIFORM DEFLECTION OF THE PLASTIC SAFETY DISK HOUSING AT THE FASTENER LOCATIONS IS APPLYING TOO MUCH STRESS ON THE DIAPHRAGM MEMBRANE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FIELD SERVICE ENGINEER (FSE) THAT DURING ROUTINE PREVENTIVE MAINTENANCE, CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED MEMBRANE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211364 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