BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHISIO APEX HP/SMART VVR SSA

    MDR report key: 2111121 · Received May 25, 2011

    Report

    Report Number
    1718850-2011-00043
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 27, 2011
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K092895
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE APEX HP OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP USA RECEIVED A REPORT THAT BLOOD AND FROTH WAS SEEN COMING FROM THE BOTTOM OF THE OXYGENATOR DURING THE CASE. THE OXYGENATOR WAS CHANGED OUT WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS INCIDENT. THE PRODUCT WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. VISUAL INSPECTION FOUND BLOOD STAINED FIBERS RUNNING THE ENTIRE LENGTH OF THE OXYGENATOR. BLOOD WAS SEEN EXITING THE GAS COMPARTMENT DURING RINSING. AUTOPSY SHOWED BLOOD STAINS ON THE ENDS OF THE FIBERS AT THE GAS INLET AND OUTLET MANIFOLD. BOTH END CAPS WERE ALSO STAINED WITH BLOOD. THE REPORT STATED THAT FROTH WAS SEEN COMING FROM THE OXYGENATOR, INDICATING THAT BLOOD WAS INSIDE A GAS FILLED FIBER. BLOOD WAS FOUND IN THE FIBERS DURING EVALUATION. THIS INDICATES A BREACH IN A FIBER SOMEWHERE IN THE BUNDLE. IT IS LIKELY THAT THE LEAK SITE BECAME PLUGGED OR SEALED OVER TIME BY DRY BLOOD COMPONENTS, EFFECTIVELY CLOSING THE FIBER(S). LEAK TESTING COULD NOT REPRODUCE A LEAK. WITHOUT AN ACTIVE LEAK SITE, THE EXACT CAUSE OF THE LEAK COULD NOT BE DETERMINED. HOWEVER, BASED ON THE ABOVE EVALUATION, IT APPEARS THAT THE CAUSE OF THE REPORTED LEAK WAS DUE TO A LEAKY FIBER. NO FURTHER ACTION IS DEEMED NECESSARY. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE PATIENT WAS VENTILATED BECAUSE OF THE OXYGENATOR CHANGE OUT. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THIS ACTION.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT BLOOD AND FROTH WAS SEEN COMING FROM THE BOTTOM OF THE OXYGENATOR DURING THE CASE. AS A RESULT OF THE LEAK, IT WAS DECIDED TO COME OFF BYPASS AND CHANGE OUT THE OXYGENATOR. THE ANESTHESIOLOGIST VENTILATED UNDER VERY STABLE CONDITIONS DURING THE CHANGE OUT WHICH TOOK NINE MINUTES. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHISIO APEX HP/SMART VVR SSA OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1012070132

    Patients

    Seq Age Sex Outcome Treatment
    1