BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 19667166 · Received July 3, 2024

    Report

    Report Number
    2249723-2024-02709
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 16, 2024
    Report Date
    January 29, 2025
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    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, G3, G6, H2, H3, H11. CORRECTED FIELDS: H3. H6-HEALTH EFFECT CODE, HEALTH EFFECT IMPACT CODE. A GETINGE FIELD SERVICE ENGINEER (FSE) FOUND SYSTEM SHUTDOWN AND AN EMERGENCY STOP WAS PERFORMED DUE TO EXCESSIVE PRESSURE BEING DETECTED IN THE TRANSDUCER THAT MEASURES THE INTRA-BALLOON PRESSURE (#124,#58). FSE STATED THAT THE SYMPTOMS DID NOT REOCCUR AFTER TWO MONTHS OF TESTING. FSE INVESTIGATED THE FOLLOWING THREE POINTS THROUGH MANIFOLD TESTS, ETC.: 1) POSSIBILITY OF POOR ATMOSPHERIC PRESSURE MEASUREMENT BY THE INTERNAL TRANSDUCER, 2) POSSIBILITY OF OVERFILLING OF HE GAS DUE TO MALFUNCTION OF SOLENOID VALVE K10, AND 3) POSSIBILITY OF MALFUNCTION OF SOLENOID VALVES K3 AND K11 RELATED TO FILLING OF HE GAS. IT WAS CONFIRMED THAT THE TIME IT TOOK TO RELEASE NEGATIVE PRESSURE WAS LONGER THAN OTHER CARDIOSAVE DEVICES (AVERAGE 1.2 SECONDS, WITHIN THE APPROPRIATE RANGE OF 4 SECONDS). A MALFUNCTION OF THE SOLENOID VALVE K10 WAS SUSPECTED. SYMPTOMS NOT REPRODUCED ON THIS MACHINE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D1, D4(VERSION OR MODEL #, CATALOG #, (UDI) #), D9, E1(EVENT SITE POSTAL CODE - 8100071), G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS & INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: H8. AN ENGINEER CHECKED THE LOG AND FOUND A HISTORY OF #124 AND #58. MORE THAN THREE GOOD FAITH EFFORTS (GFE'S) WAS RAISED TO GET REPAIR INFORMATION BUT THERE WAS NO RESPONSE RECEIVED. THE INVESTIGATION SHALL BE CLOSED NOW, IF ANY ADDITIONAL INFORMATION RECEIVED ABOUT REPAIR THE COMPLAINT WILL BE REOPENED AND UPDATED IT.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) A SYSTEM MALFUNCTION OCCURRED. #124, #58. THE DEVICE WAS RESTARTED AND TREATMENT CONTINUED, BUT THE SAME SYMPTOMS CONTINUED, SO THE PUMP WAS REPLACED WITH ANOTHER MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507171 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.