BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION PLUS 7.5FR 40CC IAB

    MDR report key: 3828928 · Received May 7, 2014

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    Report

    Report Number
    2248146-2014-00069
    Event Type
    Death
    Date Received
    May 7, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 8, 2014
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    PMA / PMN Number
    K122628
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND DECONTAMINATED PRIOR TO TESTING. VISUAL EXAMINATION FOUND TWO KINKS IN THE CATHETER TUBING APPROXIMATELY 39.6CM AND 76.2CM FROM THE TIP, HOWEVER, THE FIBER OPTIC WAS NOT DAMAGED. A SENSOR OUTPUT TEST WAS PERFORMED, WHICH TESTS THE ABILITY OF THE FIBER OPTIC SENSOR TO ACCURATELY READ PRESSURE SIGNALS AT DIFFERENT INTERVALS. IT WAS FOUND THAT THE FIBER OPTIC SENSOR WAS OPERATING PER SPECIFICATIONS. DEVICE HISTORY RECORDS WERE ALSO REVIEWED AND NO NON-CONFORMANCES WERE FOUND RELATED TO THIS EVENT. BASED ON THE RESULTS OF THE INVESTIGATION, WE WERE UNABLE TO CONFIRM THE REPORTED ISSUES AS THE RETURNED DEVICE OPERATED PER SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED HAVING AN OPTICAL SENSOR ALARM DURING THERAPY. THE FIBER OPTIC CABLE WAS UNPLUGGED AND RE-ZEROED, HOWEVER, THEY CONTINUED TO RECEIVE THE ALARM. THE PUMP WAS TURNED OFF AND RESTARTED, HOWEVER, THE UNIT CONTINUED TO ALARM. THE FIBER-OPTIC CABLE WAS THEN DISCONNECTED AND A CENTRAL AORTIC LINE WAS CONNECTED TO THE PUMP AS AN ALTERNATIVE PRESSURE SOURCE. THE PT WAS STABLE AT THIS TIME. IT WAS LATER REPORTED THAT THE PT EXPIRED, HOWEVER, IT WAS NOT RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274944 SENSATION PLUS 7.5FR 40CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP., 0684-00-0567 3048

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death