BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTA-AORTIC BALLOON PUMP

    MDR report key: 4623080 · Received March 18, 2015

    Report

    Report Number
    2249723-2015-00012
    Event Type
    Death
    Date Received
    March 18, 2015
    Date of Event
    February 20, 2015
    Report Date
    February 20, 2015
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ORIGINALLY IT WAS REPORTED THE COMPANY REPRESENTATIVE REPLACED THE POWER SUPPLY AND THE IABP IS BEING TESTED TO FACTORY SPECIFICATION; HOWEVER, THE CUSTOMER ELECTED NO TO REPAIR. THE CUSTOMER REQUESTED THE UNREPAIRED IABP TO BE RETURNED. THE MAQUET TECHNICIAN RETURNED THE IABP TO THE CUSTOMER WITHOUT THE POWER SUPPLY AND NOT RELEASED FOR CLINICAL USE. DURING THE DEVICE EVALUATION, THE SERVICE TECHNICIAN ALSO OBSERVED THAT THE FIBER OPTIC FUNCTION WAS NOT OPERATING PER THE MANUFACTURE'S SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE POWER SUPPLY WAS RECEIVED JUNE 10, 2015 AT THE MANUFACTURE FOR EXTENSIVE EVALUATION. IT WAS OBSERVED THAT THERE WERE TWO MISSING SCREWS HOLDING THE COVER AS WELL AS SOMETHING LOOSE INSIDE THE POWER SUPPLY. THE LOOSE OBJECT WAS COMPONENT CR1 THAT WAS BROKEN OFF THE CIRCUIT BOARD IN TWO PIECES, HOWEVER DUE TO THE EXTENSIVE DAMAGE INSIDE THE POWER SUPPLY, IT WOULD BE IMPOSSIBLE FOR THE MANUFACTURE TO DETERMINE THE ROOT CAUSE OF THE FAILURE. IN AN ATTEMPT TO OBTAIN THE ROOT CAUSE OF THE FAILURE THE POWER SUPPLY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION.

    Additional Manufacturer Narrative · 1

    THE COMPONENT WAS SENT TO THE VENDOR FOR EVALUATION. THE VENDOR REPORTED THAT, UPON VISUAL INSPECTION; IT WAS DISCOVERED THAT A CATASTROPHIC FAILURE HAPPENED TO THE MAIN PC BOARD, BURNING 50 % OF THE BOARD SURFACE AS WELL AS THE DAUGHTER CARD PC BOARD AT OR AROUND THE POINT OF T6, T7, C17 AND ALL PARTS OF THE Q7 OUTPUT CONVERTER. THE MOST LIKELY ROOT CAUSE IS A THOUGH BATTERY BULK VOLTAGE SHORTED THROUGH THE IDENTIFIED COMPONENTS AND CAUSE THE CATASTROPHIC FAILURE; HOWEVER, NO PRECISE ROOT CAUSE CAN BE ESTABLISHED.

    Additional Manufacturer Narrative · 1

    THE IABP IS UNDER INVESTIGATION. DIGITAL PICTURES WERE TAKEN OF THE INTRA-AORTIC BALLOON PUMP TO DOCUMENT THE TRACES OF SMOKE. THE CUSTOMER IS NOT REPORTING ANY OTHER ADD'L DAMAGES. THE COMPANY REPRESENTATIVE REPLACED THE POWER SUPPLY AND THE IABP IS BEING TESTED TO FACTORY SPECIFICATION. THE POWER SUPPLY (PART NUMBER 0014-00-0033-05) IS BEING RETURNED TO THE MANUFACTURING FACILITY IN (B)(4) FOR EVALUATION. WHEN FURTHER INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL WILL BE SENT.

    Additional Manufacturer Narrative · 1

    THE IABP IS UNDER INVESTIGATION. THE CUSTOMER IS NOT REPORTING ANY OTHER ADD'L DAMAGES. THE PRODUCTION DEVICE HISTORY RECORD (DHR) OF THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NON-CONFORMANCES IN THE PRODUCTION DHR RELATED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    IN A STORAGE ROOM OF OUT SURGERY ICU CHI1 TRIGGERED A FIRE ALARM THIS RESULTING IN A LOT OF SMOKE CAUSED BY THE CARDIOSAVE IN THE CHARGING MODE. THE CS300 WAS OBVIOUSLY OVERHEATED. THE DEVICE WAS IMMEDIATELY DISCONNECTED FROM THE MAIN SUPPLY. DUE TO THE FIRE ALARM SYSTEM THE APPROPRIATE INTERVENTION PTS DAMAGE COULD BE PREVENTED. NO PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184683 INTA-AORTIC BALLOON PUMP CS300 DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Death