BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 19539427 · Received June 14, 2024

    Report

    Report Number
    2249723-2024-02546
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    May 29, 2024
    Report Date
    February 24, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4,B5,D1,D4(UNIQUE IDENTIFIER (UDI) #),D9,E1(EVENT SITE POSTAL CODE - 8100071),G3,G6,H2,H3,H4,H6(TYPE OF INVESTIGATION,INVESTIGATION FINDINGS,INVESTIGATION CONCLUSIONS),H10. A GETINGE FIELD SERVICE ENGINEER (FSE) OBSERVED FROM THE FAULT LOG, #124 AND #58, AIR DRIVE SYSTEM FAILURE (FAILURE TO MEASURE ATMOSPHERIC PRESSURE OR SOLENOID VALVE OPERATION). FSE CONFIRMED THE TRANSDUCER OFFSET NORMAL, SOLENOID VALVE K7 OPERATION NORMAL. PRESSURE/VACUUM REGULATOR SET POINT WITHIN NORMAL RANGE (P388.3MMH= G/V-295.3MMHG). PERFORMED 30PSI CALIBRATION AND REINSTALLED SOFTWARE D.00. AN ALL-MANIFOLD TEST AND A RUNNING TEST WERE PERFORMED, AND THE UNIT WAS RETURNED AFTER CONFIRMING THAT THE SYMPTOMS DID NOT REOCCUR.

    Additional Manufacturer Narrative · 0

    PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    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 USE ON A PATIENT DISCOVERED BY HOSPITAL PERSONNEL, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM SHUTDOWN OCCURRED. THE PATIENT WAS EXPERIENCING VF, SO THE DEVICE WAS OPERATING WITH AN INTERNAL TRIGGER. THE DEVICE WAS OPERATING IN RESCUE MODE FOR PATIENT TRANSPORT. THE CATHETER CAME OFF THE DEVICE AND THE "IAB DISCONNECTED" ALARM SOUNDED, SO THE HOSPITAL STAFF (CLINICAL ENGINEER) RECONNECTED IT AND PRESSED THE START KEY, BUT A TECHNICAL ALARM SOUNDED AND PUMPING STOPPED. WHEN UNIT WAS RESTARTED, IT BEGAN WORKING NORMALLY.NO PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT DISCOVERED BY HOSPITAL PERSONNEL, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM SHUTDOWN OCCURRED. THE PATIENT WAS EXPERIENCING VF, SO THE DEVICE WAS OPERATING WITH AN INTERNAL TRIGGER. THE DEVICE WAS OPERATING IN RESCUE MODE FOR PATIENT TRANSPORT. THE CATHETER CAME OFF THE DEVICE AND THE "IAB DISCONNECTED" ALARM SOUNDED, SO THE HOSPITAL STAFF (CLINICAL ENGINEER) RECONNECTED IT AND PRESSED THE START KEY, BUT A TECHNICAL ALARM SOUNDED AND PUMPING STOPPED. WHEN UNIT WAS RESTARTED, IT BEGAN WORKING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373882 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