BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5

    MDR report key: 1062430 · Received May 31, 2008

    Report

    Report Number
    1062430
    Event Type
    Malfunction
    Date Received
    May 31, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 31, 2008
    Manufacturer
    SORIN GROUP, USA, INC.
    Product Code
    DTQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE PERFUSIONIST STATED THAT THE FALSE AIR BUBBLE ALARM WAS TRIGGERED IMMEDIATELY PRIOR TO CARDIOPULMONARY BYPASS. THE ALARM WAS DISABLED AND THE PROCEDURE CONTINUED. BIOMED ASSESSMENT: RAN THE SYSTEM FOR 6 HOURS WITH WATER IN A TEST CIRCUIT. THERE WERE NO UNEXPECTED BUBBLE ALARMS. TWO DAYS LATER, THE SORIN SERVICE REP TESTED THE UNIT AND FOUND NO PROBLEMS. BIOMED THEN RAN THE UNIT FOR ANOTHER FIVE HOURS WITH NO UNEXPECTED BUBBLE ALARMS. BIOMED RELEASED THE UNIT BACK TO SURGERY FOR USE. PREVIOUSLY, 4 DAYS BEFORE THE EVENT, THE BUBBLE SENSOR MODULE WAS REMOVED FROM THIS UNIT. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 HEART LUNG BYPASS UNIT DTQ SORIN GROUP, USA, INC. S5 *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR