BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 20824827 · Received December 2, 2024

    Report

    Report Number
    2249723-2024-0004879
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 11, 2024
    Report Date
    July 1, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE REPLACED THE SAFETY DISK (0202-00-0140). THE TEST PASSED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9(RETURN TO MANUFACTURE DATE), G3, G6, H2, H11. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF MEMBRANE LEAK TEST FAILED. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE SAFETY DISK 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 FAT OBSERVED THAT THE MEMBRANE LEAK DIFFERENTIAL TEST FAILED AT 7MMHG. THE FACTORY SPECIFICATION IS +-6MMHG. THE FAT WAS ABLE TO REPLICATE THE COMPLAINT EXPERIENCED BY THE CUSTOMER. THE SAFETY DISK FAILED TESTING. RETAINING THE SAFETY DISK IN THE FAT PER PROCEDURE NUMBER 0002-07-D008 REV.AT. ROOT CAUSE 1 - OTHER. 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. ROOT CAUSE 2 ¿ OTHER 0002-06-6833-02 CARDIOSAVE PRODUCT SPECIFICATION, REV R, DOES NOT COMPREHENSIVELY DEFINE THE ESSENTIAL PERFORMANCE PARAMETERS OF THE CARDIOSAVE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELD- B4, G3, G6, H2, H11. CORRECTED FIELD- H6- INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 EVEN SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    N/A.

    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) HAD A PIM LEAK TEST ERROR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328168 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.