BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONSOLE FOR 5 PUMP

    MDR report key: 1185823 · Received July 16, 2008

    Report

    Report Number
    1718850-2008-00016
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    k062396
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INDICATED THAT AN AIR BUBBLE ALARM WAS ENCOUNTERED DURING SET-UP AND PRIMING OF THE CARDIOPULMONARY BYPASS CIRCUIT. THE HOSP PERSONNEL BELIEVED THAT IT WAS A FALSE AIR BUBBLE ALARM IN THAT THEY COULD NOT IDENTIFY ANY AIR BUBBLES IN THE LINE. AFTER THE PROCEDURE, THE HOSP BIOMEDICAL ENGINEER PERFORMED TESTING ON THE S5 SYS AND WAS UNABLE TO DUPLICATE THE BUBBLE ALARM. ADD'L TESTING WAS PERFORMED ON SITE BY A SORIN GROUP USA, INC. SVC REP AND NO ALARMS OCCURRED. THE TESTING WAS REPEATED BY THE BIOMEDICAL ENGINEER AND STILL THE ALARM COULD NOT BE REPRODUCED. THE S5 SYS WAS PLACED BACK INTO SVC. THE REPORTED FALSE ALARM COULD NOT BE REPRODUCED BY THE BIOMEDICAL ENGINEER NOR THE SORIN GROUP USA, INC. REP. IT IS POSSIBLE THAT THE SYS ALARMED DUE TO THE PRESENCE OF MICRO AIR DISLODGED DURING PRIMING WHICH WAS NOT VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 CONSOLE FOR 5 PUMP CONSOLE, HEART LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1