BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP (IABP)

    MDR report key: 6062652 · Received October 27, 2016

    Report

    Report Number
    2249723-2016-00032
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    April 21, 2016
    Report Date
    October 7, 2016
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS PREVIOUSLY STATED, MULTIPLE ATTEMPTS WERE MADE TO THE CUSTOMER TO RETRIEVE INFORMATION REGARDING THE PATIENT AND TO RETRIEVE A CONFIRMATION OF THE EVENT, BUT WERE UNSUCCESSFUL. OTHER INDIVIDUALS WITHIN THE SAME DEPARTMENT AND WHO WERE CONTACTED DID NOT RECOLLECT ANY SUCH EVENT (I.E. UNIT MALFUNCTION AND PATIENT ADVERSE EVENT). FURTHER, THE CUSTOMER REQUESTED SERVICE ON THE UNIT ALLEGEDLY INVOLVED IN THE EVENT, AND A FULL PREVENTIVE MAINTENANCE (PM) WAS PERFORMED BY THE COMPANY SERVICE REPRESENTATIVE. THE OUTCOME OF THE PM REVEALED THE UNIT WAS FULLY FUNCTIONAL AND CONFORMED TO FACTORY SPECIFICATIONS. THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NONCONFORMANCE NOTED IN THE DHR RELATED TO THE REPORTED EVENT. THE CUSTOMER HAS REQUESTED SERVICE OF THE UNIT (CS300 IABP, S/N (B)(4)) INVOLVED IN THE EVENT AND AS REPORTED IN THIS MEDWATCH. THE COMPANY SERVICE DEPARTMENT HAS INITIATED CONTACT WITH THE CUSTOMER TO ARRANGE FOR SERVICE OF THE UNIT. THE CUSTOMER HAS REQUESTED SERVICE OF THE UNIT (CS300 IABP, S/N (B)(4)) INVOLVED IN THE EVENT AND AS REPORTED IN THIS MEDWATCH. THE COMPANY SERVICE DEPARTMENT HAS INITIATED CONTACT WITH THE CUSTOMER TO ARRANGE FOR SERVICE OF THE UNIT. THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE WERE NO NONCONFORMANCES NOTED IN THE DHR RELATED TO THE REPORTED EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    DURING FOLLOW UP COMMUNICATION BETWEEN THE COMPANY REPRESENTATIVE AND THE CUSTOMER, THE CUSTOMER REPORTED THAT THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT AND THERE WAS NO PATIENT DEATH ASSOCIATED WITH THE DEVICE. THE PATIENT IS CURRENTLY ON A TRANSPLANT LIST. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE UNIT WOULD BE GENERATING AN ALARM FOR ¿GAS LOSS¿ WHEN IN FACT NO LEAKS WERE DETECTED BY THE CUSTOMER AND IT WAS FOUND THAT ALL CONNECTION WERE SECURE. THE DEVICE WAS REBOOTED AND WORKED PER SPECIFICATIONS, AND USED TO COMPLETE THERAPY. ON (B)(6) 2016 WHEN THE COMPANY REPRESENTATIVE CALLED BACK TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER REPORTED THE PATIENT HAD SUFFERED ¿BRAIN DEATH¿. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ON WHETHER THE BRAIN DEATH OF THE PATIENT IS ATTRIBUTED TO THE DEVICE OR TO THE EVENT. THE UNIT HAS NOT BEEN UTILIZED IN THERAPY SINCE THE EVENT. MULTIPLE ATTEMPTS WERE MADE TO THE CUSTOMER TO RETRIEVE INFORMATION REGARDING THE PATIENT AND TO RETRIEVE A CONFIRMATION OF THE EVENT, BUT WERE UNSUCCESSFUL. OTHER INDIVIDUALS WITHIN THE SAME DEPARTMENT AND WHO WERE CONTACTED DID NOT RECOLLECT ANY SUCH EVENT (I.E. UNIT MALFUNCTION AND PATIENT ADVERSE EVENT).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE UNIT WOULD BE GENERATING AN ALARM FOR ¿GAS LOSS¿ WHEN IN FACT NO LEAKS WERE DETECTED BY THE CUSTOMER AND IT WAS FOUND THAT ALL CONNECTION WERE SECURE. THE DEVICE WAS REBOOTED AND WORKED PER SPECIFICATIONS, AND USED TO COMPLETE THERAPY. ON 10/07/2016 WHEN THE COMPANY REPRESENTATIVE CALLED BACK TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER REPORTED THE PATIENT HAD SUFFERED ¿BRAIN DEATH¿. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ON WHETHER THE BRAIN DEATH OF THE PATIENT IS ATTRIBUTED TO THE DEVICE OR TO THE EVENT. THE UNIT HAS NOT BEEN UTILIZED IN THERAPY SINCE THE EVENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE UNIT WOULD BE GENERATING AN ALARM FOR ¿GAS LOSS¿ WHEN IN FACT NO LEAKS WERE DETECTED BY THE CUSTOMER AND IT WAS FOUND THAT ALL CONNECTION WERE SECURE. THE DEVICE WAS REBOOTED AND WORKED PER SPECIFICATIONS, AND USED TO COMPLETE THERAPY. ON 10/07/2016 WHEN THE COMPANY REPRESENTATIVE CALLED BACK TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER REPORTED THE PATIENT HAD SUFFERED ¿BRAIN DEATH¿. THE CUSTOMER DID NOT PROVIDE ANY INFORMATION ON WHETHER THE BRAIN DEATH OF THE PATIENT IS ATTRIBUTED TO THE DEVICE OR TO THE EVENT. THE UNIT HAS NOT BEEN UTILIZED IN THERAPY SINCE THE EVENT. MULTIPLE ATTEMPTS WERE MADE TO THE CUSTOMER TO RETRIEVE INFORMATION REGARDING THE PATIENT AND TO RETRIEVE A CONFIRMATION OF THE EVENT, BUT WERE UNSUCCESSFUL. OTHER INDIVIDUALS WITHIN THE SAME DEPARTMENT AND WHO WERE CONTACTED DID NOT RECOLLECT ANY SUCH EVENT (I.E. UNIT MALFUNCTION AND PATIENT ADVERSE EVENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713617 CS300 INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death