BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE G PLUG

    MDR report key: 19430651 · Received May 30, 2024

    Report

    Report Number
    2249723-2024-02246
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 17, 2024
    Report Date
    February 11, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). IT WAS REPORTED THAT DURING BEFORE USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD PNEUMATIC INTERFACE MODULE (PIM) LEAK TEST FAILED. A GETINGE FIELD SERVICE ENGINEER (FSE) PERFORM ALL MANIFOLD TEST PIM LEAK TEST FAILED. MEMBRANE MORE THAN 6 SAFETY DISK FAILED. FSE REPLACED THE SAFETY DISK TO RESOLVE THE ISSUE. ALL MANIFOLD TEST PERFORMED AND PASS IAW FACTORY SPECIFICATION. FSE CONFIRMED UNIT TESTED PASS IAW FACTORY SPECIFICATION. UNIT HANDED TO USER. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED SAFETY DISK WITH A REPORTED UNIT FAILURE OF PIM LEAK TEST FAILED. 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 SAFETY DISK IN THE CARDIOSAVE TEST FIXTURE AND TESTED THE SAFETY DISK TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER: (B)(4) REVISION E AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER: 0070-00-0639 REVISION R. THE ALL- MANIFOLD TEST WAS PERFORMED BY THE FAT DEPT. WITH RESULTS OF THE MEMBRANE DIFFERENTIAL PRESSURE TEST FAILING AT 7MMHG. THE COMPANY SPECIFICATION IS +-6MMHG. THE FAT DEPT. WAS ABLE TO REPLICATE THE FAILURE OF THE PIM LEAK TEST FAILING. THE SAFETY DISK FAILED TESTING. RETAINING THE SAFETY DISK IN THE FAT DEPT. PER PROCEDURE NUMBER: (B)(4) REV.AR. THE NON-CONFORMANCE'S WITH THE RETURNED COMPONENTS WERE CONFIRMED. CAPA: 488804 HAS BEEN INITIATED TO ADDRESS THIS ISSUE. THE ROOT CAUSE IS DESIGN.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5)

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP)UNIT FAILED PIM LEAK TEST DURING ALL MANIFOLD TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259853 CARDIOSAVE HYBRID, TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-52 10607567108438

    Patients

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