BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION PLUS 8FR. 50CC

    MDR report key: 9903523 · Received March 31, 2020

    Report

    Report Number
    2248146-2020-00179
    Event Type
    Death
    Date Received
    March 31, 2020
    Date of Event
    January 28, 2020
    Report Date
    April 9, 2020
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    [FROM]: UNKNOWN IAB. [TO]: SENSATION PLUS 8FR. 50CC IAB CATALOG # CHANGED FROM UNKNOWN TO 0684-00-0575. SECTION D - DEVICE AVAILABLE FOR EVAL: [FROM]: [BLANK] [TO]: NO. 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). H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ELECTROCARDIOGRAM (ECG) TRIGGER DID NOT WORK, AND THERE WAS NO LEAD. THE PATIENT WAS LATER TRANSPORTED TO UNIVERSITY OF MINNESOTA HOSPITAL AND EXPIRED ON AN UNKNOWN DATE. IN ADDITION, IT HAS BEEN REPORTED THAT A UNKNOWN MAQUET 50CC BALLOON WAS USED. THERE WAS NO REPORTED MALFUNCTION ON THE IAB.

    Additional Manufacturer Narrative · 1

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ELECTROCARDIOGRAM (ECG) TRIGGER DID NOT WORK, AND THERE WAS NO LEAD. THE PATIENT WAS LATER TRANSPORTED TO UNIVERSITY OF MINNESOTA HOSPITAL AND EXPIRED ON AN UNKNOWN DATE. IN ADDITION, IT HAS BEEN REPORTED THAT A UNKNOWN MAQUET 50CC BALLOON WAS USED. THERE WAS NO REPORTED MALFUNCTION ON THE IAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371293 SENSATION PLUS 8FR. 50CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death