BEUDAMED
    FDA Adverse Event Other Summary report: N

    PE SAHARA ADULT W/VALVE

    MDR report key: 402834 · Received July 3, 2002

    Report

    Report Number
    1221601-2002-00014
    Event Type
    Other
    Date Received
    July 3, 2002
    Report Date
    July 3, 2002
    Manufacturer
    GENZYME BIOSURGERY A DIV OF GER
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THE ONE WAY VALVE IS NOT FUNCTIONING (THE VALVE NEAR THE AIRLEAK INDICATOR INSIDE THE UNIT). THE CUSTOMER ALLEGED THE UNIT WAS NOT INDICATED "YES" WHILE ON SUCTION. THE PATIENT HAD A RESECTION IN ICU AND WAS IN FOR 5 DAYS WITH CHEST TUBES AT -20 SUCTION, THE AIRLEAK WAS AT +1/+2 AND SOMETIMES 0. AFTER THE ICU, THE PATIENT WAS ON THE FLOOR 24 HOURS LATER, TAKEN OFF SUCTION, AND LEFT ON DRAINAGE. THE PATIENT WAS STILL AT +1/+2 AIRLEAK, SUDDENLY PATIENT HAD +3/+2 AIRLEAK. THE PATIENT COMPLAINED OF DISCOMFORT. THE SURGEON ALLEGED THE SYSTEM WAS NOT WORKING PROPERLY, SO HE/SHE PLACED A HEMLIC VALVE IN BETWEEN THE PATIENT AND THE SYSTEM, THEN THE PATIENT FELT BETTER. IN THE MORNING, THE PNEUMOTHORAX WAS ALMOST RESOLVED. THE CUSTOMER STATED THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    THE FOLLOWING ADDITIONAL INFO WAS PROVIDED ON 7/30/2002: THE CUSTOMER ALLEGED THE ONE-WAY VALVE DID NOT FUNCTION WHEN THE PT WAS BREATHING, AT THE INSPIRATION, THE DRAINAGE WAS GOING BACK INTO THE CHEST CAVITY. THEY ALLEGED THE SUCTION INDICATOR ALWAYS SHOWED "YES" AS THE PT WAS ON GRAVITY. ON 7/18/2002 THE CUSTOMER NOTED THE REPORTED ISSUE WITH THE NEGATIVITY IN THE LITTLE ARM OF THE AIR LEAK INDICATOR FOR BOTH OF THE CHEST TUBES AND THE BLUE FLUID FROM THOSE COLUMNS WERE SPILLING INTO THE COLLECTION CHAMBER AND THE DRAINAGE IN THE CHEST TUBE AT THE INSPIRATION OF THE PT WAS GOING BACK INTO THE PTS CHEST. AT THIS TIME, THE PHYSICIAN PLACED 2 HEMLICH VALVES ON THE THORACIC CATHETERS AND CONNECTED TO THE PLEUR-EVAC AND IT ALLEGEDLY WORKED WELL AFTER THAT. THE CHEST TUBES BUBBLED FOR TWO DAYS BEFORE THE HEMLICH VALVES WERE ADDED. THE FOLLOWING ADDITIONAL INFO WAS PROVIDED ON 8/13/2002: THE DEFECTIVE VALVE IN THE SYSTEM ALLEGEDLY ALLOWS REFLUX OF AMBIENT AIR INTO HE PLEURAL CAVITY, THEREBY PREVENTING THE LUNG FROM EXPANDING COMPLETELY, PARTICULARLY IN PTS WHO HAVE UNDERGONE EXTENSIVE PULMONARY RESECTION OR WHO PRESENT PULMONARY RIGIDITY. IN ADDITION IT WAS ALLEGED THAT THE DEFECT ALLOWS REFLUX OF THE LIQUID IN THE DRAIN TUBE INTO THE PLEURAL CAVITY, WITH A RISK OF CONTAMINATING THE CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PE SAHARA ADULT W/VALVE CHEST DRAINAGE KDQ GENZYME BIOSURGERY A DIV OF GER S-1100B 523736

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other