BEUDAMED
    FDA Adverse Event Death Summary report: N

    LINEAR 7.5 FR. 40CC IAB

    MDR report key: 17693983 · Received September 6, 2023

    Report

    Report Number
    2248146-2023-00551
    Event Type
    Death
    Date Received
    September 6, 2023
    Date of Event
    August 14, 2023
    Report Date
    September 12, 2023
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567106564
    PMA / PMN Number
    K041281
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. REFERENCE COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 0

    OCCUPATION: SENIOR BIOMED LEAD. ADDITIONAL REPORTER: (B)(6). THE DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. IT WAS DISCARDED BY THE USER. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE COMPLAINT (B)(4).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRA-AORTIC BALLOON (IAB) WAS BEING INSERTED TO ASSIST WITH WEANING THE PATIENT FROM BYPASS FOLLOWING A VALVE PROCEDURE. DURING THERAPY, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) GENERATED AN AUTOFILL FAILURE ALARM AND THE IAB WOULD NOT INFLATE. A NEW IAB WAS INSERTED BUT THE SAME ISSUE OCCURRED. AT THE TIME OF ATTEMPTING TO INITIATE THERAPY, IT WAS NOTED THAT THE PATIENT HAD ADEQUATE ELECTROCARDIOGRAM (EKG) SIGNAL TO THE IABP AND FLUID-FILLED TRANSDUCER WAS SET UP. THERE WERE NOT ANY SIGNIFICANT ISSUES WITH INSERTION. THEY DID NOT PERFORM A MANUAL FILL AT THE TIME OF INITIATION FOR EITHER IAB AND THEY DID NOT ATTEMPT TO USE ANOTHER IABP. HOWEVER, THE TECHNICIAN DID SEPARATE THE SECOND CATHETER FROM THE HELIUM TUBING AND FELT HELIUM FLOWING OUT OF THE HELIUM EXTENDER TUBING. IT WAS ALSO NOTED THAT WHEN THE SECOND IAB WAS REMOVED, THERE WAS DRIED BLOOD OBSERVED ON THE CATHETER AND WHEN INFLATION WAS ATTEMPTED IT WAS SOMEWHAT STUCK TOGETHER. FOLLOWING THE FAILURE TO INITIATE IAB SUPPORT, THE PATIENT WAS THEN PLACED ON EXTRACORPOREAL LIFE SUPPORT (ECLS) AND TAKEN FROM THE OPERATING ROOM (OR) FOR A SHORT PERIOD OF TIME. BLEEDING WAS SUSPECTED AS THE PATIENT DECOMPENSATED. THE PATIENT WAS THEN BROUGHT BACK TO THE OR, PLACED ON BYPASS AGAIN, AND THE PROCEDURE WAS REPEATED/ESCALATED TO TOTAL REPLACEMENT OF THE VALVE IN QUESTION. BLEEDING WAS CONFIRMED, AT THAT TIME, AND THE NECESSITY TO REDO THE PROCEDURE. THE PHYSICIAN DECIDED NOT TO PLACE PATIENT ON ECLS AGAIN, OR ATTEMPT ANOTHER IAB. THE PATIENT WAS SCHEDULED TO BE TRANSFERRED TO ANOTHER FACILITY, BUT THE TERTIARY CARE FACILITY WOULD NOT ACCEPT THE PATIENT SINCE THEY WERE NOT ON ECLS SUPPORT. PATIENT WAS THEN TRANSFERRED TO THE ICU WHERE THEY EXPIRED SHORTLY AFTER. THIS REPORT IS FOR THE 2ND IAB USED IN THIS EVENT. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE 1ST IAB UNDER MFG REPORT NUMBER 2248146-2023-00550. AN ADDITIONAL REPORT FOR THE CARDIOSAVE IABP USED IN THIS EVENT HAS BEEN SUBMITTED UNDER MFG REPORT NUMBER 2249723-2023-03813.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225259 LINEAR 7.5 FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD UNKNOWN 10607567106564

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Death CARDIOSAVE / (B)(6)