BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 18939238 · Received March 20, 2024

    Report

    Report Number
    2249723-2024-01186
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    March 11, 2024
    Report Date
    January 23, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    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 FIELDS: B4, D1, D4(VERSION OR MODEL #, CATALOG #, UDI #), D9, E1(EVENT SITE POSTAL CODE - 0030027), G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H10. A GETINGE FIELD SERVICE ENGINEER EVALUATED CLEANED THE INSIDE OF THE MAIN UNIT AND CONDUCTED AN INSPECTION BASED ON THE INSPECTION RECORD SHEET. DURING USER INSPECTIONS BY STAFF, IT IS POINTED OUT THAT SAFETY DISC LEAKAGE TESTS SOMETIMES FAIL. FSE CONDUCTED AN ALL MANUAL TEST, BUT ALL PASSED, BUT JUST TO BE SAFE, REPLACED THE SAFETY DISK AND TESTED FOR LEAKAGE, BUT THE LAST TEST DID NOT PASS, SO INSTALLED ANOTHER NEW SAFETY DISK AND PASSED THE TEST. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS SAFETY DISK, SAFETY DISK . THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF LEAK TEST FAILS. PERFORMED VISUAL INSPECTION OF THESE PARTS RECEIVED AND ALL PARTS LOOKS TO BE IN GOOD CONDITION. INSTALLED SAFETY DISKS INTO THE CARDIOSAVE TEST FIXTURE AND TESTED SEPARATELY TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION R. FOR SAFETY DISK: THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF LEAK TEST FAILS. SAFETY DISK PASSED TESTING WITH RESULT OF LEAK DIFF. PRES. -3MMHG, THE FACTORY SPECIFICATION IS +- 10MMHG. RETAINING THIS SAFETY DISK IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AQ. FOR ANOTHER SAFETY DISK: THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF LEAK TEST FAILS. SAFETY DISK PASSED TESTING WITH RESULT OF LEAK DIFF. PRES. 0MMHG, THE FACTORY SPECIFICATION IS +- 10MMHG. RETAINING THIS SAFETY DISK IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AQ.THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INSPECTIONS BY STAFF, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SAFETY DISC LEAK TEST DID NOT PASS SEVERAL TIMES. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485991 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown