BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872032 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00375
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE COULD NOT CONFIRM THE "AIR DETECTED" ALARM CONDITION WHEN HE GAINED ACCESS TO THE TWO PUMPS ON (B)(6) 2013. HE REPLACED THE HELIUM TANK AND THE BATTERY (PART NUMBER D146-00-0039), COMPLETED AN INSPECTION WITH FULL CALIBRATION, FUNCTIONAL TESTING, AND SAFETY CHECK TO FACTORY SPECIFICATIONS. THE IABP FUNCTIONED NORMALLY AND THE COMPANY REPRESENTATIVE RETURNED THE IABP TO THE CUSTOMER. (SECOND PUMP RELATED TO THIS EVENT SERIAL NUMBER (B)(4): MFR REPORT #2249723-2014-00374. REF: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED "AIR DETECTED" ALARM AND THE IABP STOPPED PUMPING. THE CUSTOMER VERIFIED THERE WERE NO PHYSICAL SIGNS OF BLOOD ON THE IABP TUBING AND REPLACED THE IAB BUT THE ALARM PERSISTED. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND SYMPTOM OCCURRED AGAIN. THE PATIENT WAS SWITCHED TO A THIRD IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235548 CS300 INTRA0AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other