BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION PLUS 8FR. 50CC IAB

    MDR report key: 16095587 · Received January 4, 2023

    Report

    Report Number
    2248146-2023-00013
    Event Type
    Death
    Date Received
    January 4, 2023
    Date of Event
    December 19, 2022
    Report Date
    April 11, 2023
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    UDI-DI
    10607567108605
    PMA / PMN Number
    K112327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INITIAL REPORTER NAME & OCCUPATION - (B)(6), ICU RN. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT RECORD ID # (B)(4).

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY BLOOD WAS SEEN WITHIN THE HELIUM TUBING. THE CUSTOMER WAS ADVISED TO STOP THERAPY IMMEDIATELY AND CALL THE PHYSICIAN TO REMOVE THE BALLOON WITHIN 30 MINUTES DUE TO RISK OF THROMBUS. UPON FOLLOW UP ON (B)(6) 2022 AT 8:44AM, IT WAS DISCOVERED THAT THE PHYSICIAN ORDERED THE STAFF TO CONTINUE RUNNING THE IAB DESPITE THE INSTRUCTIONS FOR USE (IFU) STATING TO STOP THERAPY AND REMOVE THE IAB. AT 11:15AM, RECEIVED WORD FROM THE LOCAL TEAM THAT THE PHYSICIAN ELECTED NOT TO REMOVE THE IAB DUE TO RISK OF THROMBOSIS. DUE TO THE PATIENT¿S CLINICAL CONDITION, THE TEAM FELT HE WOULD NOT TOLERATE BEING UNDER ANESTHESIA FOR A VASCULAR PROCEDURE THUS THE IAB WAS NOT REMOVED. THE PATIENT WAS PUT ON COMFORT CARE. AT 1:43PM, RECEIVED WORD FROM THE LOCAL TEAM THAT THE PATIENT EXPIRED WITH THE IAB IN PLACE AS IT WAS UNABLE TO BE REMOVED SAFELY.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200489 SENSATION PLUS 8FR. 50CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 0684-00-0576-01 3000255396 10607567108605

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Death CARDIOSAVE / CH342371J1.