BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION PLUS 7.5FR. 40CC IAB

    MDR report key: 6538901 · Received May 2, 2017

    Report

    Report Number
    2248146-2017-00036
    Event Type
    Death
    Date Received
    May 2, 2017
    Date of Event
    January 31, 2017
    Report Date
    May 2, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K122628
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 05/02/2017 03:57 PM (GMT-4:00) ADDED BY (B)(4). THE DEVICE WAS NOT RETURNED AND COULD NOT BE EVALUATED. THE DEVICE IS NOT AVAILABLE FOR RETURN. WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    FULL AUGMENTATION COULD NOT BE ACHIEVED DUE TO INTRA AORTIC BALLOON PUMP (IABP) ALARM. THE PATIENT EXPIRED AFTER THE PROCEDURE ON (B)(6) 2017. THE DEATH IS NOT ATTRIBUTED TO THE DEVICE BY THE FACILITY. THE INTRA AORTIC BALLOON (IAB) COULD NOT BE RETURNED AS IT REMAINED INSERTED IN THE EXPIRED PATIENT IN THE HOSPITAL MORGUE AND CAN NOT BE ACCESSED. THE SERIAL NUMBER IS NOT AVAILABLE AND NO OTHER DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318774 SENSATION PLUS 7.5FR. 40CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death