BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS300

    MDR report key: 3893608 · Received June 11, 2014

    Report

    Report Number
    2249723-2014-00713
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    DATASCOPE CORP.,
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP VISITED THE FACILITY AND WAS UNABLE TO DUPLICATE THE COMPLAINT. IT WAS DISCOVERED THAT THE TOP COVER OF THE UNIT WAS CRACKED. THE COMPANY REP STATED ON (B)(4) 2014 THAT THIS CRACKED TOP COVER WAS NOT RELATED TO THE DISPLAY. THE TOP COVER CRACKED WHEN THE CUSTOMER ACCIDENTALLY LOWERED A TABLE ONTO THE CONSOLE. THE COMPANY REP REPLACED THE TOP COVER (PART 0380-00-0497), TOP COVER INSULATOR (PART 0349-00-0348), AND THE LABEL (PART 0334-00-1635-01). THE CRACKED TOP COVER WAS DISPOSED OF BY THE CUSTOMER. THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE PRODUCTION DEVICE RECORD FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE ARE NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    THE PT WAS 5' 7". THE BALLOON THERAPY BEGAN ON SATURDAY (B)(6) 2014. THE CUSTOMER STATED THEY WOULD LOSE THE PRESSURE WAVEFORM. THEY WERE ABLE TO FLUSH THE LUMEN A FEW TIMES AND WERE ABLE TO ZERO AND RE-ESTABLISH THE PRESSURE WAVEFORM. THE PROBLEM OCCURRED A FEW TIMES BETWEEN SATURDAY ((B)(6) 2014). THE CUSTOMER SUPPLIED STRIPS SHOWING DAMPENING AND LOSS OF WAVEFORMS. AFTER THE DEVICE LOST ALL PT WAVEFORMS, THE DISPLAY WENT BLANK. THE THERAPY WAS NEVER INTERRUPTED. THE CS300 CONTINUED TO PUMP. AT APPROXIMATELY 4:00PM ON MONDAY ((B)(6) 2014), THEY SWITCHED CONSOLES. THE CUSTOMER DID NOT HAVE ANY MORE WAVEFORM ISSUES. THE PT EXPIRED ON MONDAY EVENING AT 10PM. THE PT WAS VERY SICK AND UNSTABLE. THE CUSTOMER IS NOT ATTRIBUTING THE DEATH TO THE BALLOON PUMP. CONTACT NURSE MGR ICU (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344900 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP., CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death