BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21078449 · Received January 6, 2025

    Report

    Report Number
    2249723-2025-0000095
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 19, 2024
    Report Date
    April 30, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: H6 (MEDICAL DEVICE ¿ PROBLEM CODE). THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE FILL MANIFOLD ASSEMBLY (0997-00-0565). THE UNIT PASSED ALL PERFORMANCE AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER.

    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 DATE), G3, G6, H2, H6 (COMPONENT CODES), H11 CORRECTED FIELDS: H6 (INVESTIGATION CONCLUSIONS). THE FSE THAT ENCOUNTERED THE ISSUE REPLACED THE FILL MANIFOLD ASSEMBLY (0997-00-0565). THE UNIT PASSED ALL PERFORMANCE AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER. THE FOLLOWING INVESTIGATION WAS PERFORMED BY (B)(4), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ CF 03 APR MAR 2025. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 HELIUM FILL ASSEMBLY SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF FAILING THE FILL MANIFOLD 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 0997-00-0565 HELIUM FILL ASSEMBLY SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE HELIUM FILL ASSEMBLY TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER (B)(4) REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT PERFORMED THE ALL MANIFOLD TEST AND WAS ABLE TO REPLICATE THE COMPLAINT EXPERIENCED BY THE CUSTOMER OF THE FILL MANIFOLD TEST FAILING, WITH A RESULT OF THE FILL VALVE DIFFERENTIAL PRESSURE AT 15MMHG. THE FACTORY SPECIFICATION IS +-12MMHG. THE HELIUM FILL ASSEMBLY FAILED TESTING. RETAINING THE HELIUM FILL ASSEMBLY IN THE FAT PER PROCEDURE NUMBER (B)(4) REV. AT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382114 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