BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19801265 · Received July 22, 2024

    Report

    Report Number
    2249723-2024-02934
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 2, 2024
    Report Date
    January 9, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G3, G6, H2, H3, H4, H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS, H11. CORRECTED FIELD: D4 (UDI). A GETINGE FIELD SERVICE ENGINEER FSE EVALUATED THE UNIT AND COMPRESSOR TIGHTLY SECURED TO CHASSIS COMPRESSOR OUTPUT TEST PASSED AT 1437 RPM NO STRANGE NOISES BEEN PRODUCED BY COMPRESSOR AND IABP PUMPING SMOOTHLY FSE ANALYZED LOGS AND FOUND ELECTRICAL TEST FAILURE 118 SOL WDT FAIL A CRITICAL ERROR DETECTED IN THE HARDWARE WATCH DOG CIRCUIT ON THE SOLENOID DRIVER BOARD RECORDED 43 TIMES SOLENOID CONTROL PCB 0670-00-1161 SN (B)(6) EDM WAS REMOVED AND REPLACED WITH 0670-00-1161 SN (B)(6) EDM DRIVE MANIFOLD AND EXECUTIVE PROCESSOR WERE ALSO INSPECTED AND CONNECTIONS VERIFIED BLOOD PRESSURE ADAPTER CABLE WAS REPLACED DUE TO A BROKEN PIN DISCOVERED WHILE PERFORMING THE FIBER OPTIC TEST SAFETY DISK SN (B)(6) CONSISTENTLY FAILING THE MEMBRANE LEAK TEST PORTION OF THE PNEUMATIC INTERFACE MODULE LEAK TEST MEMBRANE DIFF PRESSURE READING 8MMHG EXCEEDING THE ALLOWABLE SPECIFICATION 6 +/- MMHG SAFETY DISK WAS REPLACED WITH 0202-00-0140 SN (B)(6) TIDAL VOLUME DISK ALSO REPLACED PIM LEAK TEST NOW PASSED 9V DAUGHTER BOARD BATTERY AND QUICK DISCONNECT ORING REPLACED FSE COMPLETED FULL PM WITH CALIBRATION AND THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE THE FOLLOWING INVESTIGATION WAS PERFORMED BY CARL FAMULARE TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT FAT WAYNE NJ CF 23 AUG 2024 THE FAILURE ANALYSIS AND TESTING DEPT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1161 SOLENOID CONTROL PCBA SERIAL NUMBER (B)(6) EDM THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE FOR PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) FOR THE MEMBRANE LEAK TEST PART NUMBER 0670-00-1161 SOLENOID CONTROL PCBA SERIAL NUMBER (B)(6) EDM FAILED FOR ELECTRICAL TEST FAILURE 118 SOL WDT FAIL THE FAILURE ANALYSIS AND TESTING DEPT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION THE FAILURE ANALYSIS AND TESTING DEPT INSTALLED PART NUMBER 0670-00-1161 SOLENOID CONTROL PCBA SERIAL NUMBER (B)(6) EDM IN THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R AFTER AN EXTENDED RUNIN TIME OF 4 HOURS THE FAT DEPT COULD NOT REPLICATE THE FAILURE THAT THE CUSTOMER EXPERIENCED OF ELECTRICAL CODE 118 THE BOARD PASSED TESTING THE FAILURE ANALYSIS AND TESTING DEPT INSTALLED PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) IN THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE SAFETY DISK TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER (B)(4) AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R THE FAT DEPT COULD NOT REPLICATE THE FAILURE OF THE SAFETY DISK FAILING THE MEMBRANE DIFFERENTIAL TEST THE SAFETY DISK PASSED TESTING THE NONCONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT IDENTIFIED HOWEVER THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED SENDING PART NUMBER 0670-00-1161 SOLENOID CONTROL PCBA SERIAL NUMBER (B)(6) EDM TO THE SUPPLIER PER PROCEDURE NUMBER (B)(4) RETAINING PART NUMBER 0202-00-0140 SAFETY DISK SERIAL NUMBER (B)(6) IN THE FAT DEPT THE FOLLOWING WAS SUBMITTED BY (B)(4) TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT FAT WAYNE NJ AR 6 NOV 2024 FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PART 0670-00-1161 PLEASE SEE ATTACHMENT THEY STATED 1 PERFORM VISUAL CHECK RESULT NO ABNORMALITIES FOUND 2 BOARD WAS RETESTED AT FCT RESULT PASSED NDF RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED BOARD WAS NDF NO FAILURE CONFIRMED RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4) THE NONCONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT IDENTIFIED HOWEVER THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    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 DURING PREVENTATIVE MAINTENANCE BY 3RD PARTY CONTRACTOR, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAS A COMPRESSOR MOTOR ISSUE. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479159 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