BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21146772 · Received January 14, 2025

    Report

    Report Number
    2249723-2025-0000196
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    November 27, 2024
    Report Date
    November 12, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELDS: H6 (MEDICAL DEVICE ¿ PROBLEM CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9 (DEVICE RETURN DATE), G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H6 (MEDICAL DEVICE ¿ PROBLEM CODE, TYPE OF INVESTIGATION, COMPONENT CODES, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) H11, IT WAS REPORTED THAT DURING USE THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN AND WHEN POWERING BACK UP THE PUMP, AN ERROR MESSAGE INDICATED THAT THE SAFETY DISK NEEDED TO BE REPLACED. PATIENT INVOLVED AND NO HARM REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE SHUT DOWN ISSUE. FOUND MULTIPLE ONE WIRE LAN ERRORS IN ERROR LOG. CONFIGURATION WAS ONLY SHOWING VIDEO GEN AND DISPLAY BOARDS. REPLACED EXEC BOARD AND BACKPLANE BOARD AND PROBLEM PERSISTED. FINALLY TROUBLESHOT THE FAILURE TO THE POWER SLOT INTERFACE BOARD WHICH APPEARS HAVE SALINE DAMAGE TO IT. REPLACED BOARD. DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. DEVICE WAS GIVEN TO CUSTOMER AND CLEARED FOR CUSTOMER USE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY CARL FAMULARE, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0997-00-1189 SLOT INTERFACE BOARD SERIAL NUMBER (B)(6) PART NUMBER 0670-00-0770 EXEC PROCESSOR BOARD SERIAL NUMBER (B)(6) PART NUMBER 0670-00-1163 BACKPLANE BOARD SERIAL NUMBER (B)(6) THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF PUMP SHUT DOWN. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND OBSERVED HEAVY SALINE ON PART NUMBER 0997-00-1189 SLOT INTERFACE BOARD SERIAL NUMBER 17 03302 15_SWEMCO. THE FAT OBSERVED SALINE ON PART NUMBER 0670-00-1163 BACKPLANE BOARD SERIAL NUMBER (B)(6). THE FAT ALSO OBSERVED SALINE ON PART NUMBER 0997-00-1189 SLOT INTERFACE BOARD SERIAL NUMBER (B)(6). PLEASE NOTE: A MICROSCOPE WAS USED TO EXAMINE THE BOARDS. PLEASE SEE ATTACHMENTS. DUE TO THE SALINE ON THE BOARDS, THE FAT DEPT. CANNOT INVESTIGATE THIS COMPLAINT ANY FURTHER. PROBABLE CAUSE OF THE SHUTDOWN COMPLAINT WAS THE SALINE WHEN IT SPILLED ON ALL THREE BOARDS. RETAINING THE BOARDS IN THE FAT DEPT. PER PROCEDURE NUMBER (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) SHUT DOWN. UPON POWERING BACK UP THE PUMP, AN ERROR MESSAGE INDICATED THAT THE SAFETY DISK NEEDED TO BE REPLACED. THERE WAS NO HARM OR INJURY REPORTED.

    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
    1897965 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