BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22359288 · Received June 30, 2025

    Report

    Report Number
    2249723-2025-0002784
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 14, 2025
    Report Date
    July 22, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, G3, G6, H2, H11.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G1 (CONTACT PERSON MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE STATES, CUSTOMER REPORTS AUTOFILL ERROR. REPLACED HELIUM RESERVOIR ASSEMBLY (0997-00-0565). EXORCISED TO NO FAIL COMPLETED REPAIR SUCCESSFULLY. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0997-00-0565 WITH A REPORTED UNIT FAILURE OF AN AUTOFILLING ERROR. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED THE PART IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS BEING SET UP FOR PATIENT USE, BUT BEFORE THERAPY WAS INITIATED, THE DEVICE EXPERIENCED AN AUTOFILL ERROR. NO PATIENT HARM WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) EXPERIENCED AN AUTOFILL ERROR. NO PATIENT HARM WAS IDENTIFIED.

    Description of Event or Problem · 0

    N.A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969783 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