BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 2669916 · Received July 18, 2012

    Report

    Report Number
    3004468271-2012-00030
    Event Type
    Injury
    Date Received
    July 18, 2012
    Date of Event
    November 26, 2010
    Report Date
    June 18, 2012
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER MEDIBO MEDICAL PRODUCTS (B)(4). ALTHOUGH MANY UNKNOWN VARIABLES EXIST IN THIS CASE, ARJOHUNTLEIGH DOES NOT EXPECT TO GET MUCH MORE INFORMATION DUE TO THE PENDING LITIGATION BETWEEN THE FAMILY OF THE RESIDENT AND THE CUSTOMER FACILITY. THEREFORE THE INVESTIGATION WILL BE BASED ON THE AVAILABLE DATA RELATED WITH THE PREVIOUS SIMILAR CASES. TREND REVIEW: DURING THE REVIEW OF REPORTABLE COMPLAINTS 18 CASES WITH SIMILAR RESULT DESCRIPTION (BONE FRACTURES) WERE FOUND: (B)(4) - RELATED WITH THIS INVESTIGATION, (B)(4) (2012). IN 17 OF ALL FOUND CASES, THE ISSUE WAS RELATED WITH USE ERROR (PATIENT NOT PROPERLY ASSESSED PRIOR THE LIFT USAGE - PATIENT LOST CONSCIOUSNESS, FRACTURE CAUSED BY OSTEOPOROSIS, PATIENT AGITATED, RAISED ARMS; WRONG SLING USED, SLING SAFETY STRAP NOT ATTACHED, ETC.). FROM (B)(6) 2010 TO (B)(6) 2012, MEDIBO AND AHP MANUFACTURED ABOUT (B)(4) LIFTS 'SARA 3000'. WITH THE AMOUNT OF SOLD DEVICES AND WITH COMPARISON TO THE DAILY USE OF THEM THERE IS NO PARTICULAR TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE ON SARA 3000. ROOT CAUSE ANALYSIS: THE CUSTOMER FACILITY NEVER INFORMED ARJOHUNTLEIGH ABOUT THE INCIDENT WHEN IT HAD OCCURRED (IN 2010). LIFT WAS NOT RETURNED TO AHP, DEVICE EXAMINATION WAS NOT DONE, NO ADDITIONAL INFORMATION ABOUT LIFT AND SLING ARE AVAILABLE. BASED UPON THE COURSE OF EVENTS REPORTED THE MOST PROBABLY INITIAL CAUSE OF A PATIENT LEGS BREAKAGE IS RELATED WITH USE ERROR. THE SARA 3000 IFU DESCRIBES THE TRANSFER PROCEDURE THAT IS TO BE FOLLOWED. THIS TRANSFER PROCEDURE IS WRITTEN TO INDICATE THAT: THE SARA 3000 IS TO BE USED TO TRANSFER A PERSON OVER SHORT DISTANCES FROM ONE SUPPORTED POSITION TO ANOTHER. IN BETWEEN AND WHILE THE RESIDENT IS RAISED, IT IS ALLOWED TO MAKE ANY NECESSARY ADJUSTMENTS TO CLOTHING, INCONTINENCE PADS, ETC., BEFORE LOWERING AGAIN. THE PERSON BEING TRANSFERRED IS TO BE LIFTED INTO A STANDING POSITION. THIS IS IMPORTANT BECAUSE WHEN IN THE STANDING POSITION AND WITH KNEES LOCKED THE STRAIN OF STANDING UP IS NO LONGER TAKEN BY THE MUSCLES AND THE PATIENT'S SKELETAL SYSTEM. IF THE IFU IS NOT FOLLOWED ON THESE POINTS THE PERSON BEING TRANSFERRED WILL HAVE TO USE EFFORT TO HOLD ON TO THE LIFT DEVICE, AND WILL HAVE GROWING PRESSURE ON THEIR MUSCLES. IF THE CHEST SUPPORT STRAP IS NOT FITTED SUFFICIENTLY SNUGLY AND THE SLING IS NOT MONITORED TO STAY IN PLACE AT THE LOWER BACK, THE SLING CAN CREEP UP THE BACK AND GO ALL THE WAY TO AND OVER THE SHOULDERS, PINCHING THE UPPER ARMS. AS A RESULT, IF THE PERSON IS ELDERLY OR HAS OTHER PATHOLOGIES THAT INDICATE BRITTLE BONES, THERE IS A SIGNIFICANT CHANCE THEY CAN BREAK A SHOULDER OR ARM OR WILL RAISE THE ARMS AND SLIP OUT OF SLING TO THE FLOOR, WHICH CAN CAUSE OTHER FRACTURES. THERE IS NO INFORMATION IF THE LEG STRAPS WAS USED. ACCORDING TO THE INSTRUCTION FOR USE: 'AN ASSESSMENT MUST BE MADE FOR EACH INDIVIDUAL RESIDENT BEING RAISED BY THE SARA 3000 - BY A MEDICALLY QUALIFIED PERSON - AS TO WHETHER THE RESIDENT REQUIRES THE LOWER LEG STRAPS WHEN USING THE STANDING SLING. USE IF NECESSARY, E.G. WITH UNRULY RESIDENTS, RESIDENTS WITH SPASMS, ETC. THAT WERE ASSESSED AS SUITABLE TO BE RAISED WITH THE SARA 3000. DO NOT USE THE LEG FIXATION STROP WHEN USING THE TRANSFER SLING.' THAT ALL LEAVES US TO CONCLUDE THAT THERE MIGHT BE A PATHOLOGY OR USE ERROR THAT RESULTED IN THE BROKEN LEG. SOME FORMS OF OSTEOPOROSIS CAN CAUSE BONE BREAK WITHOUT STRAIN, AND CAN OCCUR ANYWHERE. THEREFORE, THE ROOT CAUSE OF CLAIMED EVENT MIGHT BE THE LACK OF FULL CLINICAL ASSESSMENT PRIOR TO DEVICE USE: BONE BREAKAGE POTENTIAL (CONNECTED WITH THE PATIENT'S AGE/HEALTH STATE). LACK OF FULL CLINICAL ASSESSMENT IS ALSO CONSIDERED TO BE A USE ERROR. ACCORDING TO INSTRUCTION FOR USE: 'BEFORE ATTEMPTING TO USE SARA 3000, A FULL CLINICAL ASSESSMENT OF THE RESIDENT HIS/HER CONDITION, AND SUITABILITY MUST BE CARRIED OUT BY A QUALIFIED PERSON.' FINAL CONCLUSIONS: WE HAVE BEEN ABLE TO THEORETICALLY DUPLICATE THE FAILURE MODE OF THIS EVENT. THERE IS NO PARTICULAR COMPLAINT TREND. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.

    Description of Event or Problem · 1

    FACILITY'S LAWYER CONTACTED ARJOHUNTLEIGH ABOUT AN INCIDENT FROM 2010 WHICH WAS DESCRIBED AS FOLLOWS: DURING A TRANSFER USING THE SARA 3000, A RESIDENT SUFFERED A FRACTURE TO ONE OF THEIR LEGS (UNCLEAR IF THEY FELL TO THE FLOOR). THE LAWYER STATES THAT THERE ARE DIFFERENT REPORTS ON WHETHER OR NOT THE LEG STRAPS WERE ATTACHED. THIS FACILITY NEVER INFORMED AHUS ABOUT THE INCIDENT WHEN IT HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFTS FSA MEDIBO MEDICAL PRODUCTS NV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization