BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALPHA TRANCELL DELUXE

    MDR report key: 6342304 · Received February 18, 2017

    Report

    Report Number
    3005619970-2017-00005
    Event Type
    Death
    Date Received
    February 18, 2017
    Date of Event
    January 12, 2017
    Report Date
    March 3, 2017
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #(B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. AHUS (REGISTRATION #(B)(4)). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT WHICH OCCURRED WITH THE ALPHA TRANCELL DELUXE SYSTEM INVOLVEMENT. IT WAS INDICATED THAT THE PATIENT WHO WAS LOCATED ON THE MATTRESS HAS DEVELOPED PRESSURE ULCER (STAGE 4) OVERNIGHT. THE MATTRESS WAS OBSERVED TO BE INFLATED DURING THE NIGHT CHECK AT 10:30 P.M. IN THE MORNING OF THE NEXT DAY, AT 07:30 A.M. THE PATIENT WAS FOUND LYING ON A FLAT MATTRESS. THE POWER CABLE OF THE PUMP WAS FOUND DISCONNECTED - THE POWER WAS NOT SUPPLIED TO THE SYSTEM WHICH RESULTED IN MATTRESS DEFLATION. NO PRODUCT MALFUNCTION WAS FOUND UPON THE SYSTEM EVALUATION. THE PATIENT DIED ON (B)(6) 2017 (ABOUT THREE WEEKS AFTER THE REPORTED INCIDENT). IT WAS INDICATED THAT PATIENT'S DEATH WAS NOT A RESULT OF A DEVELOPED INJURY, HOWEVER, PATIENT'S CONDITION PRIOR TO THE EVENT OR THE EXACT MEDICAL CAUSE OF PATIENT'S DEATH WERE NOT ESTABLISHED BY ARJOHUNTLEIGH. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND NO OTHER CASE PRESENTING A SIMILAR SCENARIO. THE OCCURRENCE RATE OBSERVED FOR THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE VERY LOW. FOLLOWING THE INFORMATION GATHERED, IT WAS POSSIBLE TO INDICATE THE MOST LIKELY SCENARIO OF THE REPORTED EVENT. IT WAS REPORTED THAT THE PATIENT WAS FOUND ON A DEFLATED MATTRESS WHICH INDICATES A LOW PRESSURE CONDITION OCCURRED IN THE SYSTEM. A LOW PRESSURE IS USUALLY A RESULT OF AIR LEAKAGE WITHIN THE PUMP OR MATTRESS ASSEMBLY OR AN INSUFFICIENT AIR SUPPLY. IT WAS CONFIRMED THAT THE POWER CABLE OF THE PUMP WAS NOT PLUGGED IN WHICH CONSEQUENTLY RESULTED IN AIR LEAKAGE AND MATTRESS DEFLATION. THE SYSTEM WAS EVALUATED BY ARJOHUNTLEIGH REPRESENTATIVE WHO DID NOT DISCOVER ANY SOURCE OF SYSTEM LEAKAGE. MATTRESS AND PUMP WERE TESTED AS A SYSTEM AND PERFORMED UP TO THEIR SPECIFICATIONS. DESIGNED ALARMS, INCLUDING A POWER FAIL ALARM, WERE CONFIRMED TO BE FULLY FUNCTIONAL. THE POWER FAIL ALARM IS POWERED BY A RECHARGEABLE BATTERY. THE DURATION OF THE ALARM WILL DEPEND ON THE LEVEL OF CHARGE IN THE BATTERY. THE BATTERY MAY HAVE BECOME DISCHARGED OR REACHED THE END OF ITS LIFE. THE ALPHA TRANCELL DELUXE SYSTEM INSTRUCTION FOR USE ( 649933_02) THEREFORE RECOMMENDS TO TEST THE ALARM BEFORE THE PUMP IS USED. THE POWER INDICATOR WILL FLASH WHEN A MAINS POWER FAILURE HAS BEEN DETECTED. THE ALARM WILL CONTINUE UNTIL THE MAINS POWER IS RESUMED OR UNTIL THE RUN/STANDBY BUTTON IS PRESSED AND HOLD. TAKING INTO CONSIDERATION THAT THE SYSTEM WAS SERVICED ONE MONTH BEFORE THE INCIDENT, IT IS UNLIKELY THAT THE CHARGE LEVEL IN THE BATTERY WAS TOO LOW. IT APPEARS MOST LIKELY THAT THE POWER FAIL ALARM WAS LAUNCHED DURING THE THERAPY BUT WAS IGNORED. ALPHA TRANCELL DELUXE SYSTEM IS INDICATED FOR THE PREVENTION AND/OR MANAGEMENT OF ALL CATEGORIES OF PRESSURE ULCERS WHEN COMBINED WITH AN INDIVIDUALIZED, COMPREHENSIVE PRESSURE ULCER PROTOCOL, INCLUDING REPOSITIONING, NUTRITIONAL SUPPORT, SKIN CARE. THE SYSTEM REPRESENTS ONLY ONE ASPECT OF PRESSURE ULCER MANAGEMENT PROTOCOL - ALL OTHER ASPECTS OF CARE SHOULD BE CONSIDERED BY THE PRESCRIBING CLINICIAN. [INSTRUCTION FOR USE, 500934EN_01]. DESPITE A FULLY FUNCTIONAL DESIGNED MITIGATION FACTOR (A POWER FAIL ALARM) WHICH WAS ALERTING THE CAREGIVER ABOUT A PROBLEM WITH ALPHA TRANCELL DELUXE SYSTEM, NO IMMEDIATE ACTION WAS TAKEN BY THE CUSTOMER FACILITY STAFF. IT APPEARS MOST LIKELY THAT THE PATIENT WAS NOT REGULARLY MONITORED (ACCORDING TO RECOMMENDATION INCLUDED IN THE IFU) WHICH MAY CONTRIBUTED TO THE EVENT. ALTHOUGH THE TIME SPENT BY PATIENT ON A DEFLATED MATTRESS AND HIS CONDITION PRIOR TO THE EVENT REMAINED UNKNOWN, A SERIOUS PRESSURE INJURY (PRESSURE ULCER STAGE IV) OCCURRED AND THE PATIENT DIED THREE WEEKS AFTER THE REPORTED EVENT. AS PER THE INDICATION OF THE FACILITY, THE PATIENT'S DEATH WAS NOT DIRECTLY LINKED TO THE INJURY DEVELOPED EARLIER. IT WAS NOT POSSIBLE TO ESTABLISH THE EFFECT WHICH THE PRESSURE SORE POSED ON A GENERAL HEALTH STATE OF THE PATIENT, ANYWAY, IT MIGHT HAVE SIGNIFICANTLY CONTRIBUTED TO DETERIORATION OF THE OVERALL HEALTH CONDITION. THE POSSIBLE SEQUENCE OF EVENTS PRESENTED ABOVE SEEMS TO BE THE MOST PROBABLE AND IN LINE WITH THE EVENT DESCRIPTION. THE ROOT CAUSE OF THE REPORTED EVENT IS CONSIDERED TO BE USE ERROR- IN INTERRUPTION OF THE THERAPY WAS NOT NOTICED IN A TIMELY MANNER, DESPITE A FULLY FUNCTIONAL DESIGNED MITIGATION FACTOR IN PLACE. IT HAS BEEN ESTABLISHED THAT THE ALPHA TRANCELL DELUXE SYSTEM WAS BEING USED FOR A PATIENT THERAPY AT THE TIME OF THE EVENT BUT HAS NOT MALFUNCTIONED (DID PERFORM UP TO SPECIFICATION), HOWEVER ITS USE ERROR HAS CONTRIBUTED TO THE OUTCOME OF THE EVENT.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT WHICH OCCURRED WITH THE INVOLVEMENT OF ALPHA TRANCELL DELUXE SYSTEM. IT WAS INDICATED THAT THE PATIENT WHO WAS LOCATED ON THE MATTRESS HAS DEVELOPED PRESSURE ULCER (STAGE 4) OVERNIGHT. THE MATTRESS WAS OBSERVED TO BE INFLATED DURING THE NIGHT CHECK AT 22:30. AT 07:30 IN THE MORNING THE PATIENT WAS FOUND LYING ON A FLAT MATTRESS. THE POWER CABLE OF THE PUMP WAS FOUND DISCONNECTED. THE POWER WAS NOT SUPPLIED TO THE SYSTEM WHICH RESULTED IN MATTRESS DEFLATION. THE PATIENT DIED ON (B)(6) 2017. IT WAS INDICATED BY THE FACILITY THAT PATIENT'S DEATH WAS NOT A DIRECT RESULT OF A DEVELOPED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124968 ALPHA TRANCELL DELUXE MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death