BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIII 3-POS CONSOLE

    MDR report key: 1288969 · Received January 14, 2009

    Report

    Report Number
    1718850-2008-00037
    Event Type
    Death
    Date Received
    January 14, 2009
    Date of Event
    December 8, 2008
    Report Date
    December 15, 2008
    Manufacturer
    SORIN GROUP DEUTSCHLAND, (SORIN GROUP USA, INC. IS DISTRIBUTOR)
    Product Code
    DTQ
    PMA / PMN Number
    K950990
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR NARRATIVE. THE SIII PUMP IS MANUFACTURED BY ANOTHER COUNTRY'S MFR AND DISTRIBUTED. A SORIN GROUP USA, INC. SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO EVALUATE THE PUMP. THE SORIN GROUP USA, INC. SERVICE REPRESENTATIVE FOUND NO PROBLEMS AND DETERMINED THAT THE SIII PUMP WAS FUNCTIONING PROPERLY. SORIN GROUP USA REPRESENTATIVE CONTACTED THE PERFUSIONIST AND THE HOSPITAL'S RISK MANAGEMENT REPRESENTATIVE IN AN ATTEMPT TO OBTAIN MORE INFO REGARDING THE EVENT. HOSPITAL PERSONNEL DECLINED TO PROVIDE ADDITIONAL INFO TO SORIN GROUP USA, INC. REPRESENTATIVES. THE FACILITY DID NOT RETURN THE PUMP TO SORIN GROUP USA. AS A RESULT, NO FURTHER EVALUATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    BASED ON INFO PROVIDED TO SORIN GROUP USA, INC., THE HOSPITAL BRIEFLY LOST POWER DURING AN ECMO CASE, REPORTEDLY DUE TO CONSTRUCTION AND/OR RENOVATION. THE HOSPITAL'S BIOMEDICAL ENGINEER REPORTED THAT THE NURSE(S) BELIEVED THE PUMP WAS SLOWING DOWN, AND PROCEEDED TO HAND CRANK THE PUMP. IT WAS REPORTED THAT THE PT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIII 3-POS CONSOLE PERFUSION SYSTEM DTQ SORIN GROUP DEUTSCHLAND, (SORIN GROUP USA, INC. IS DISTRIBUTOR) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death