BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON ACS800 TRI PULSE

    MDR report key: 5646817 · Received May 11, 2016

    Report

    Report Number
    3005619970-2016-00008
    Event Type
    Injury
    Date Received
    May 11, 2016
    Report Date
    April 8, 2016
    Manufacturer
    GETINGE (SUZHOU) CO., LTD.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION (E2012066) BY ARJOHUNTLEIGH, INC. (B)(4) ON BEHALF OF THE MANUFACTURER (GETINGE (SUZHOU) CO., LTD.) (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2016 ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT A PATIENT SUSTAINED 3 STAGE PRESSURE SORES ON HER CALVES AFTER FLOWTRON ACS800 TRIPULSE SYSTEM WAS INSTALLED. IT WAS NOTICED THAT ON THE RIGHT CALF THE SORES DIMENSIONS WAS 3CM*1CM AND ON THE LEFT CALF IT WAS 3CM*2CM. CAREGIVER REMOVED GARMENTS AS SOON AS THEY SAW THE PRESSURE SORES. ON 19 APR 2016 ADDITIONAL INFORMATION WAS RECEIVED WHERE IT WAS REPORTED THAT THE SORES APPEARED AFTER THE GARMENTS WERE PUT ON THE PATIENT'S LEGS. CAREGIVERS SAID NO SORES WERE THERE BEFORE THE GARMENTS WERE PUT ON. THE SALESMAN INFORMED US THAT THE PATIENT INVOLVED IS AT HIGH RISK FOR SORES. THIS PATIENT IS INTUBATED, VENTILATED, CATECHOLAMINE.

    Additional Manufacturer Narrative · 1

    ON 17 MAY 2016 THE FOLLOWING ADDITIONAL INFORMATION HAS BEEN RECEIVED: THE FLOWTRON ACS800 TRI PULSE PUMP IS WORKING ACCORDING TO SPECIFICATIONS AND IS STILL IN USE WITH THIS PARTICULAR PATIENT. THE TRI PULSE GARMENTS WERE REPLACED BY A DVT ONES. TRI PULSE 20 GARMENTS WERE INVOLVED IN THE EVENT, IT WAS THE CORRECT SIZE FOR THE PATIENT. ACCORDING TO THE NURSES, THESE GARMENTS WERE APPLY CORRECTLY. THE NURSES SPECIFIED THAT A TENSIOMETER WAS INSTALLED ONLY ON THE PATIENT'S RIGHT LEG SOME DAYS PRIOR THE INCIDENT TO MEASURE BLOOD PRESSURE REGULARLY. NOBODY CAN SAY IF IT COULD HAVE LED TO PRESSURE SORES (AND ONLY ON THE RIGHT LEG). ON 13 JUNE 2016 AN INCIDENT DESCRIPTION FORM (IDF) HAS BEEN ATTACHED TO THE COMPLAINT RECORD. ACCORDING TO THIS, THE AWARENESS DATE SHOULD BE CHANGED TO 8 APR 2016 INSTEAD OF 12 APR 2016. THEREFORE, CORRECTION HAS BEEN MADE TO THE RELEVANT POINTS REPORT DATE, DATE RECEIVED BY MFR. WE ARE AWARE THAT THE INITIAL REPORT WHICH WAS SUBMITTED TO FDA ON 11 MAY 2016 PAST THE 30 DAYS DEADLINE FOR REPORTING. THE SERVICE UNIT HAS NOT FORWARDED TO THE MANUFACTURER THE INFORMATION ABOUT THE EVENT UNTIL AFTER THE DEADLINE, DUE TO PROCESSING ERRORS. WE HAVE REMINDED THEM TO REVIEW FDA REPORTING GUIDELINES IN ORDER TO PREVENT THIS FROM HAPPENING AGAIN. ON 13 JUNE 2016 ADDITIONAL INFORMATION REGARDING THE CUSTOMER ADDRESS (POINT IN THIS REPORT HAS BEEN CORRECTED) AND DETAILS CONCERN THE EVENT HAVE BEEN RECEIVED. IT WAS INDICATED THAT DRESSING WAS APPLIED ON PATIENT'S PRESSURE SORES ON BOTH CALVES. GARMENTS CONDITION WAS INDICATED TO BE "GOOD". AN INVESTIGATION WAS CARRIED OUT INTO THE COMPLAINT. FOLLOWING THE INFORMATION REPORTED THE PATIENT SUSTAINED 3 STAGE PRESSURE SORES ON BOTH CALVES AFTER TRIPULSE GARMENTS APPLICATION. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES ASSOCIATED WITH THE GARMENT TUBING CAUSING PRESSURE POINT ON LIMB. COMPARED TO THE AMOUNT OF SOLD GARMENTS THE OCCURRENCE RATE OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CONSIDERED TO BE VERY LOW. IT CAN BE ESTABLISHED THAT THE DVT PREVENTION SYSTEM CONSISTING OF FLOWTRON AC800 TRIPULSE PUMP AND TRIPULSE 20 GARMENTS WAS BEING USED FOR PATIENT CARE WHEN THE EVENT TOOK PLACE AND IN THAT WAY CONTRIBUTED TO THE OUTCOME OF THE EVENT. THE SYSTEM WAS CHECKED BY OUR TECHNICIAN AND NO MALFUNCTIONS WERE FOUND. FOLLOWING THE ABOVE THE DVT PREVENTION SYSTEM WAS FOUND TO HAVE BEEN TO SPECIFICATION WHEN THE EVENT TOOK PLACE, BUT IT APPEARS IT CONTRIBUTED TO THE EVENT DUE TO A USE ERROR. BASED ON COLLECTED INFORMATION TO DATE, WE BELIEVE THAT THE PRESSURE SORES ON PATIENT CALF WERE A RESULT OF THE TUBING RESTING ON THE CALVES AND PROBABLY WAS NOT REGULARLY REPOSITIONED. IT IS WORTH NOTING THAT IT WAS INDICATED THAT THE PATIENT INVOLVED IS AT HIGH RISK OF PRESSURE SORES. THE TREATMENT WITH USE OF ARJOHUNTLEIGH SYSTEMS NEEDS TO BE COMBINED WITH AN INDIVIDUALIZED MONITORING PROGRAM. IT WAS NOTICED THAT THE PATIENT'S PRESSURE SORES HAVE SPECIFIC DIMENSIONS: RIGHT CALF 3CM*1CM AND THE LEFT CALF 3CM*2CM AND MATCH UP TO GARMENTS USED FOR TREATMENT. THIS IS AN INDICATION THAT THE PRESSURE POINTS WERE AT THE SAME PLACE FOR A LONG TIME AND FINALLY RESULTED IN PRESSURE SORES. IN ACCORDANCE TO THE INSTRUCTION FOR USE (IFU) THE TUBING NEEDS TO BE POSITIONED AWAY FROM THE PATIENT'S LIMB, HOWEVER IT SEEMS THAT THIS RECOMMENDATION HAS NOT BEEN MET. - "GARMENTS SHOULD BE POSITIONED TO PREVENT SUSTAINED PRESSURE POINTS ON THE SKIN, PAYING PARTICULAR ATTENTION TO PATIENTS WHO ARE UNCONSCIOUS, CANNOT FEEL OR HAVE REDUCED SENSATION AND/OR ABILITY TO MOVE THEIR LEG(S)." FURTHERMORE IN THE IFU THERE IS STATED THAT GARMENTS SHOULD BE REMOVED REGULARLY TO INSPECT THE SKIN. BY REGULARLY CHECKING OF THE CONDITION OF THE SKIN, THIS ELIMINATES THE RISK OF SKIN INDENTATIONS OCCURRING. BASED ON THE INFORMATION PROVIDED THE PATIENT SUSTAINED 3 STAGE PRESSURE SORES ON BOTH CALVES AFTER GARMENTS USAGE. IT APPEARS TO BE HIGHLY UNLIKELY THAT THIS SERIOUS TYPE OF PRESSURE SORES CAN BE RESULT OF GARMENTS APPLICATION WHILE THE DEVICE IS USED AS INTENDED AND THE PATIENT IS MONITORED AS IT IS DESCRIBED IN THE IFU. THIS IS SHOWN BY THE ABSENCE OF COMPLAINTS VOLUME WITH SIMILAR SCENARIO WHEN COMPARED TO THE AMOUNT OF SOLD DEVICES. THEREFORE, THE ADDITIONAL FACTOR SUCH AS HIGH RISK OF PRESSURE SORES FOR THIS PATIENT CAN CONTRIBUTE TO SUCH SERIOUS OUTCOME. IN CONCLUSION, A COMBINATION OF PATIENT'S CONDITIONS REPORTED AND LACK OF POSITIONING OF THE TUBES OF BOTH GARMENTS CONTRIBUTED TO THE REPORTED OUTCOME OF EVENT, AS DESCRIBED. ARJOHUNTLEIGH IDENTIFIED TOWARDS THE CUSTOMER STAFF THE NEED TO CORRECTLY FIT THE GARMENT SO AS TO AVOID INCIDENTS OF THIS NATURE OCCURRING. WE ALSO ADVISE IN THE IFU THAT PATIENTS USING THESE GARMENTS ARE TO BE REGULARLY CHECKED / MONITORED TO ENSURE THERAPY IS BEING PROVIDED. BASED ON ALL COLLECTED INFORMATION TO DATE WE BELIEVE THAT THE ROOT CAUSE OF THIS PROBLEM IS LACK OF TRAINING. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301690 FLOWTRON ACS800 TRI PULSE JOW JOW GETINGE (SUZHOU) CO., LTD. 513004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other