BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19461929 · Received June 4, 2024

    Report

    Report Number
    2249723-2024-02340
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 24, 2024
    Report Date
    June 24, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H6 (HEALTH EFFECT ¿ CLINICAL & IMPACT CODE). ADDITIONAL CONTACT INFORMATION: (B)(6).

    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).

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D8, D9, G3, G6, H2, H3, H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, TYPE OF INVESTIGATION), H11. CORRECTED FIELD: E1: EMAIL ADDRESS. BIOMED REPLACED THE SAFETY DISKS. THEY WORKED CORRECTLY. THE SERVICE WAS COMPLETED BY THE CUSTOMER. GETINGE SERVICE WAS NOT REQUESTED. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0202-00-0140 REV J, SN: (B)(6) SAFETY DISK. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF MEMBRANE LEAK TEST WOULD NOT PASS. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED SAFETY DISKS INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION R. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF MEMBRANE LEAK TESTS WOULD NOT PASS. SAFETY DISK PASSED TESTING WITH RESULT OF MEMBRANE LEAK DIFF. PRES. OF 4MMHG, THE FACTORY SPECIFICATION IS +-6 MMHG. RETAINING SAFETY DISK IN THE FAT DEPT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0202-00-0140 REV J, SN: (B)(6) SAFETY DISK. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF MEMBRANE LEAK TEST WOULD NOT PASS. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED SAFETY DISKS INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION R. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF MEMBRANE LEAK TESTS WOULD NOT PASS. SAFETY DISK PASSED TESTING WITH RESULT OF MEMBRANE LEAK DIFF. PRES. OF 4MMHG, THE FACTORY SPECIFICATION IS +-6 MMHG. RETAINING SAFETY DISK IN THE FAT DEPT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOUND DURING PM SERVICE (IN-HOUSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD OUT OF BOX FAILURES ON TWO NEW SAFETY DISKS. CUSTOMER REPORTED THAT TWO OF THE NEW SAFETY DISKS WOULD NOT PASS THE MEMBRANE LEAK TEST WHEN INSTALLED INTO A CARDIOSAVE. THERE WAS NO PATIENT INVOLVEMENT.

    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 THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD OUT OF BOX FAILURES ON TWO NEW SAFETY DISKS. CUSTOMER REPORTED THAT TWO OF THE NEW SAFETY DISKS WOULD NOT PASS THE MEMBRANE LEAK TEST WHEN INSTALLED INTO A CARDIOSAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610018 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown