BEUDAMED
    FDA Adverse Event Death Summary report: N

    SARA 3000

    MDR report key: 7539764 · Received May 24, 2018

    Report

    Report Number
    3007420694-2018-00114
    Event Type
    Death
    Date Received
    May 24, 2018
    Date of Event
    March 24, 2018
    Report Date
    May 24, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O.O
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ON 2 MAY 2018, AN ARJO REPRESENTATIVE WAS INFORMED ABOUT AN ADVERSE EVENT WHICH OCCURRED IN (B)(6) LOCATED IN THE NETHERLANDS. DURING VISIT AT THE CUSTOMER FACILITY WHICH TOOK PLACE ON 8 MAY 2018, IT WAS CLARIFIED THAT PARTIALLY PARALYZED RESIDENT (80 YEAR OLD FEMALE) FELL FROM THE SARA 3000 ACTIVE FLOOR LIFT DURING A TRANSFER. AS A CONSEQUENCE OF THE FALL, THE RESIDENT SUSTAINED ARM FRACTURES. THE AMBULANCE WAS CALLED AND SHE WAS SENT TO THE HOSPITAL. DUE TO HER WEAK MEDICAL CONDITION, THE SURGEON DECIDED TO POSTPONE TREATMENT. SHE WAS SENT BACK TO THE FACILITY WITH PAIN MEDICATION AND WOUND TREATMENT. AFTER A FEW DAYS THE RESIDENT BEGAN TO HAVE BREATHING DIFFICULTIES. THE AMBULANCE PERSONNEL SAID THAT "IT LOOKED LIKE EMBOLISM / BLOOD CLOT PROBABLY CAUSED BY HER ARM FRACTURE." SHE DIED A FEW HOURS LATER, ON (B)(6) 2018. THE SARA 3000 DEVICE INVOLVED IN THE EVENT IS AN ACTIVE RESIDENT LIFT INTENDED TO BE USED WITH CLIP SLINGS. ACCORDING TO THE INSTRUCTION FOR USE (IFU, KKX81010M-EN REV.10), THE SARA 3000 IS DEDICATED FOR RESIDENT WHO: SITS IN A WHEELCHAIR, IS ABLE TO PARTIALLY BEAR WEIGHT ON AT LEAST ONE LEG, HAS SOME TRUNK STABILITY, DEPENDENT ON CARER IN MOST SITUATIONS. AS PER IFU WARNING "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." THIS MEANS THAT THE RESIDENT SHALL HAVE AN ACTIVE PARTICIPATION IN THE TRANSFER PROCESS - FROM RAISING THE RESIDENT TO THE STANDING POSITION, UP TO THE TRANSFER WITH THE LIFT. IN OTHER WORDS, THE INTENDED USER GROUP AS INDICATED IN THE DEVICE LABELING, IS TO BE MENTALLY AND PHYSICALLY CAPABLE OF AT LEAST PARTIAL STANDING CAPABILITY AND STABILITY. UPON THE COURSE OF THE INVESTIGATION, THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER FACILITY STAFF: "ALL CAREGIVERS KNEW THAT THE SARA 3000 WAS NOT THE CORRECT DEVICE TO TRANSFER THE CLIENT, BUT THE CLIENT DID NOT ACCEPTED ANY OTHER TREATMENT/TRANSFER...ESPECIALLY NOT WITH A PASSIVE LIFTER." IN REGARD TO THIS INFORMATION, ARJO ASSUMPTION IS THAT IF THE IFU WOULD HAVE BEEN FOLLOWED AND THE FULL CLINICAL ASSESSMENT OF THE RESIDENT CONDITION, AND SUITABILITY WOULD HAVE BEEN CARRIED OUT, THE EVENT COULD HAVE BEEN AVOIDED. IT WILL BE RECOMMENDED TO MAKE THE CUSTOMER AWARE THAT THE INTENDED USER GROUP AS INDICATED IN THE DEVICE LABELING, IS TO BE MENTALLY AND PHYSICALLY CAPABLE OF AT LEAST PARTIAL STANDING CAPABILITY AND STABILITY. IF THE PATIENT/RESIDENT DOES NOT MEET THESE CRITERIA, AN ALTERNATIVE EQUIPMENT/SYSTEM (PASSIVE LIFT) SHOULD BE USED. WHEN REVIEWING THE REPORTABLE EVENTS FOR SARA 3000 AND SIMILAR ACTIVE LIFTS, WE HAVE FOUND A NUMBER OF CASES RELATED TO THIS TYPE OF EVENT: PATIENT NOT SUITED FOR USE WITH THE DEVICE. IN SUMMARY, THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT AND PLAYED A ROLE IN THE REPORTED INCIDENT. THERE WAS NO FAILURE FOUND WITH THE SLING, NOR THE INVOLVED FLOOR LIFT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE RESIDENT'S FALL. WE REPORT THIS EVENT TO COMPETENT AUTHORITY AS THE ADVERSE EVENT OCCURRED.

    Description of Event or Problem · 0

    ON 2 MAY 2018, AN ARJO REPRESENTATIVE WAS INFORMED ABOUT AN ADVERSE EVENT WHICH OCCURRED IN (B)(6) NURSING HOME LOCATED IN THE (B)(6). DURING VISIT AT THE CUSTOMER FACILITY WHICH TOOK PLACE ON (B)(6) 2018, IT WAS CLARIFIED THAT PARTIALLY PARALYZED RESIDENT ((B)(6) FEMALE) FELL FROM THE SARA 3000 ACTIVE FLOOR LIFT DURING A TRANSFER. AS A CONSEQUENCE OF THE FALL, THE RESIDENT SUSTAINED ARM FRACTURES. THE AMBULANCE WAS CALLED AND SHE WAS SENT TO THE HOSPITAL. DUE TO HER WEAK MEDICAL CONDITION, THE SURGEON DECIDED TO POSTPONE TREATMENT. SHE WAS SENT BACK TO THE FACILITY WITH PAIN MEDICATION AND WOUND TREATMENT. AFTER A FEW DAYS THE RESIDENT BEGAN TO HAVE BREATHING DIFFICULTIES. THE AMBULANCE PERSONNEL SAID THAT "IT LOOKED LIKE EMBOLISM / BLOOD CLOT PROBABLY CAUSED BY HER ARM FRACTURE." SHE DIED A FEW HOURS LATER, ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382304 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH POLSKA SP Z O.O HEA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H