BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS300

    MDR report key: 5215317 · Received November 10, 2015

    Report

    Report Number
    2249723-2015-01006
    Event Type
    Death
    Date Received
    November 10, 2015
    Date of Event
    October 10, 2015
    Report Date
    October 12, 2015
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    02/26/2016 06:08 PM (GMT-5:00) ADDED BY (B)(4): THE CABLE (PART NUMBER: 0012-00-1422) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND NO FAILURE WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPANY REPRESENTATIVE REPLACED THE COILED IABP CABLE (PART NUMBER: 0012-00-1422). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE DEVICE HISTORY RECORD FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE ARE NO NONCONFORMANCES RELATED TO THE REPORTED EVENT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING USE ON PATIENT, THE IABP DISPLAY ON THE MONITOR OF CS300 SYSTEM WAS NOT WORKING AS USUAL. THE DISPLAY HAD A SPORADICALLY RED-BLUE DELAY FOR APPROX. 1 SEC ONLY. THE THERAPY CONTINUED ON THE SAME IABP. TWO DAYS LATER THE PATIENT DIED HOWEVER WAS NOT ATTRIBUTABLE TO THE DEVICE OR TO THE EVENT. A REPLACEMENT DEVICE HAS BEEN AVAILABLE, BUT WAS NOT NECESSARY. THE IAB THERAPY WAS COMPLETED UPON THE PATIENT DEATH ON THE IABP WHICH THE REPORTED FAILURE OCCURRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING USE ON PATIENT, THE IABP DISPLAY ON THE MONITOR OF CS300 SYSTEM WAS NOT WORKING AS USUAL. THE DISPLAY HAD A SPORADICALLY RED-BLUE DELAY FOR APPROX. 1 SEC ONLY. THE THERAPY CONTINUED ON THE SAME IABP. TWO DAYS LATER THE PATIENT DIED HOWEVER WAS NOT ATTRIBUTABLE TO THE DEVICE OR TO THE EVENT. A REPLACEMENT DEVICE HAS BEEN AVAILABLE, BUT WAS NOT NECESSARY. THE IAB THERAPY WAS COMPLETED UPON THE PATIENT DEATH ON THE IABP WHICH THE REPORTED FAILURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745074 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH D998-00-3023-61

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death