BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22584889 · Received July 24, 2025

    Report

    Report Number
    2249723-2025-0003160
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    July 10, 2025
    Report Date
    March 4, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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, H3, H6 (INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS, COMPONENT CODE), H11, E3. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THEY REPLACED HELIUM REGULATOR (0103-00-0637) AND ASSY, HELIUM RESERVOIR (D997-00-0565). REPAIRS WERE CONDUCTED SUCCESSFULLY AND THE PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0103-00-0637 WITH A REPORTED UNIT FAILURE OF THE HELIUM TANK RELEASES ALL THE GAS RANDOMLY. 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. HELIUM TANK WOULD NOT RELEASE ALL THE GAS ONCE INSTALLED. FOUND THAT THE HELIUM WOULD LEAK SLOWLY EXCEEDING THE FACTORY SPECIFICATIONS. PROBABLE ROOT CAUSE FOR THIS COULD BE WEAR AND TEAR. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AU. ROOT CAUSE 1 (DEFECTIVE/SUPPLIER): CONTAMINANTS MAY NOT BE FULLY REMOVED DURING THE SUPPLIER CLEANING PROCESS OF THE CARDIOSAVE HIGH PRESSURE REGULATOR (0103-00-0637)

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT BEFORE USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD INTERMITTENT HELIUM LEAK AND HOLD PRESSURE AS DESIGNED FOR SEVERAL HOURS & THEN AUDIBLY PURGE ALL HELIUM TO ATMOSPHERE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370270 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 N/A.