BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 23269720 · Received October 10, 2025

    Report

    Report Number
    2249723-2025-0004237
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 19, 2025
    Report Date
    January 22, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11, D9, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS,MEDICAL DEVICE ¿ PROBLEM CODE, COMPONENT CODES, INVESTIGATION CONCLUSIONS) A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THE NIT HAD LARGE QUANTITIES OF BLOOD WITHIN THE MECHANISM. BLOOD LEAKED OUT BETWEEN PIM AND SAFETY DISK. THE FSE REMOVED THE CONTAMINATED PARTS: PIM (D997-00-1178) , SAFETY DISK (0202-00-0140), THERMAL PRINTER (D161-00-0024-04). PRINTER PCB (D670-00-1168), POWER MANAGEMENT PCB(D670-00-1162) , PNEUMATIC BOARD(D670-00-1167). SEVERAL SCREWS WERE ALSO DISCARDED AS PART OF THE BLOOD BACK, REQUIRING A PM KIT SCREW KIT AND A PNEUMATIC ASSEMBLY SCREW KIT. AFTER REPAIR, THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER LIMIT IN E1 INITIAL REPORTER NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    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) BALLOON RUPTURED. NO MALFUNCTION REPORTED PRIOR TO BLOOD BACK EVENT. HOWEVER, BLOOD BACK DESTROYED POWER MANAGEMENT BOARD, SO UNIT WILL NO LONGER POWER ON. THERAPY WAS INTERRUPTED. POWER BOARD WAS ENTIRELY DESTROYED FROM BLOOD CONTAMINATION. PATIENT INVOLVED, NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478611 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 41 YR Female BALLOON