BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21281541 · Received January 31, 2025

    Report

    Report Number
    2249723-2025-0000476
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    January 13, 2025
    Report Date
    August 13, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    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. CORRECTED FIELDS: D1, D4 (VERSION OR MODEL, CATALOG , UNIQUE IDENTIFIER). THE H4 FIELD SHOULD BE LEFT BLANK. KINDLY REVERT. THE FSE REPLACED THE SAFETY DISK (0202-00-0140) AND TIDAL VOLUME (0202-00-0142) TO KEEP BOTH PARTS IN THE SAME PM INTERVAL. ALL FUNCTIONAL AND SAFETY CHECKS PERFORMED TO MEET FACTORY 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 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) WITH A REPORTED UNIT FAILURE OF FAILING THE MEMBRANE LEAK TEST. 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 PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE SAFETY DISK TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER 0002-07-D016 REVISION F AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. THE FAT PERFORMED THE ALL MANIFOLD TEST. THE SAFETY DISK PASSED ALL TESTING. THE FAT DEPT. COULD NOT CONFIRM THE MEMBRANE LEAK TEST FAILING. THE SAFETY DISK PASSED TESTING. RETAINING THE SAFETY DISK IN THE FAT DEPT. PER PROCEDURE NUMBER 0002-07-D008 REV. AU.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: D9, H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS).

    Description of Event or Problem · 0

    IT WAS REPORTED DURING PREVENTIVE MAINTENANCE THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SAFETY DISK WAS REPLACED WITH A NEW UNOPENED SAFETY DISK. DURING PIM LEAK CHECK NEW SAFETY DISK FAILED THE FOURTH MEMBRANE LEAK CHECK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127474 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