BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S5 CONSOLE FOR 4 PUMP

    MDR report key: 1749500 · Received July 1, 2010

    Report

    Report Number
    1718850-2010-00119
    Event Type
    Malfunction
    Date Received
    July 1, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 3, 2010
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTQ
    PMA / PMN Number
    K080832
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 CONSOLE. THE GAS BLENDER IS A COMPONENT OF THE S5 CONSOLE. THE 510(K) NUMBER FOR THE GAS BLENDER IS K080832. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). ALTHOUGH, THE PERFUSIONIST CHECKED THE GAS BLENDER PRIOR TO BYPASS, HE NOTED THAT THE ARTERIAL BLOOD WAS BLACK. AFTER THE CONNECTIONS IN THE BACK OF THE UNIT WERE READJUSTED, THE BLENDER WORKED PROPERLY. THE BIOMED HAS SINCE CHECKED ALL OTHER BLENDER LINES. NO PROBLEMS WERE FOUND. AFTER THE READJUSTMENT, THE BLENDER WAS USED FOR ANOTHER CASE WITHOUT INCIDENT. HOWEVER, THE PERFUSIONIST EXPRESSED CONCERN THAT THIS TYPE OF EVENT COULD REOCCUR. THE BLENDER HAS BEEN SHIPPED TO SORIN GROUP (B)(4) FOR FURTHER EVALUATION. A FOLLOW-UP REPORT WILL BE FILED WHEN THE EVALUATION IS COMPLETE. THERE WAS NO REPORT OF PATIENT INJURY. HOWEVER, IT WAS STATED THAT ANESTHESIA BAGGED THE PATIENT. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    PRIOR TO BYPASS, THE PERFUSIONIST HAD SET THE BLENDER TO 100% FIO2 AND THREE LITERS OF SWEEP GASS. THERE WERE NO ALARMS INDICATING THAT THE GAS WAS NOT FLOWING. AT THE START OF BYPASS, THE PERFUSIONIST NOTICED THAT THE ARTERIAL BLOOD WAS DARK. THEY IMMEDIATELY CAME OFF OF PUMP. THE HOSE CONNECTIONS IN THE BACK OF THE UNIT WERE CHECKED. A HISSING NOISE WAS HEARD. THE LINES WERE READJUSTED AND THE HISSING STOPPED. THE LINES WERE THEN UNPLUGGED TO VERIFY ALARM FUNCTION. BYPASS RESUMED WITH NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S5 CONSOLE FOR 4 PUMP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ SORIN GROUP DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1