BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAFLOW CENTRIFUGAL PUMP SYSTEM

    MDR report key: 6260446 · Received January 18, 2017

    Report

    Report Number
    8010762-2017-00011
    Event Type
    Death
    Date Received
    January 18, 2017
    Date of Event
    January 6, 2017
    Report Date
    February 27, 2017
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST HAS BEEN MADE FOR THE RETURN OF THE DEVICE ON 31-01-2017. THE SSU CONTACT INFORMED US THAT THE DEVICE WOULD BE AVAILABLE FROM 02-02-2017. ON THE 22-02-2017 ANOTHER REQUEST WAS SENT FOR THE RETURN OF THE DEVICE. HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED FROM THE CUSTOMER. MORE FOLLOW WILL BE MADE FOR THE RETURN OF THE DEVICE. AS NO PROPER INFORMATION WAS PROVIDED REGARDING THE REPORTED INCIDENT, THUS NO RISK ANALYSIS COULD BE DETERMINED. THE ONLY INFORMATION REPORTED WAS THAT AN ERROR OCCURRED AND THAT THE DEVICE ¿QUIT WORKING¿. NO FURTHER DETAILS REGARDING THE ERROR WERE PROVIDED. ALSO NO ANALYSIS COULD BE DETERMINED IF THERE WERE ANY PREVIOUS MDRS RELATED TO THIS REPORTED INCIDENT. NO SOFTWARE CHANGES WERE MADE TO THE DEVICE SINCE 1998 AS CONFIRMED WITH THE REGULATORY DEPARTMENT. AT THIS TIME, NO FURTHER ACTIONS CAN BE TAKEN UNTIL THE DEVICE HAS BEEN RETURNED AND INVESTIGATED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER NEW INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTAFLOW DRIVE QUIT WORKING DURING PATIENT TREATMENT. CUSTOMER PUT ANOTHER DRIVE ON THE ROTAFLOW CONSOLE AND ALL WORKED, NO ISSUES WITH THE CONSOLE. PERFUSION DEPARTMENT CONFIRMED THE EVENT DATE (B)(6) 2017. AND IT WAS ALSO REPORTED THAT THE PATIENT HAD A BRAIN BLEED AND WAS TAKE OFF LIFE SUPPORT AND PASSED AWAY. TIME OF DEATH 13:08 ON (B)(6) 2017. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45839 ROTAFLOW CENTRIFUGAL PUMP SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG ROTAFLOW DRIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death