BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA 3000

    MDR report key: 6427743 · Received March 23, 2017

    Report

    Report Number
    3007420694-2017-00064
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    January 28, 2017
    Report Date
    March 23, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O.O
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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). ARJOHUNTLEIGH RECEIVED THE CUSTOMER COMPLAINT RELATED TO SARA 3000 DEVICE. IT WAS REPORTED THAT THE DEVICE WAS POSITIONED IN FRONT OF THE PATIENT WHO WAS POSITIONED IN REGULAR WHEELCHAIR. PRIOR TO COMMENCING TO LIFTING PROCEDURE, THE LEGS OF THE DEVICE WERE OPENED AND BRAKES WERE NOT APPLIED, A SLING WAS NOT YET APPLIED TOO. WHEN THE RESIDENT STOOD UP AND TOOK BOTH HANDLES OF THE SARA 3000, HIS FEET WERE STILL ON THE GROUND (NOT POSITIONED YET ON THE FOOTPLATE OF THE SARA 3000). THE RESIDENT CANNOT LIFT HIS FEET ANYMORE TO STAND ON SARA 3000 BASE AND HIS SHOE TRAPPED UNDER THE FOOTPLATE. THE PATIENT WANTED TO HELP TO FREE ITS FOOT, BUT DUE TO HIS PHYSICAL CONDITION, HIS LEGS AND BODY WERE BEING OVERSTRETCHED (AS A RESULT OF A BIG PHYSICAL EFFORT) AND SUBSEQUENTLY PROPER POSITIONING OF THE LEGS WAS NOT POSSIBLE. THE RESIDENT WAS KEEPING HIS HANDS ON THE SARA 3000 LIFTING ARM. AS A CONSEQUENCE OF THAT, THE LIFTING DEVICE WAS MOVED FORWARD AND THE PATIENT FALLS DOWN BACKWARDS. AS AN OUTCOME THE BRUISING ON THE PATIENT'S FOREHEAD WAS REPORTED. NEITHER MEDICAL INTERVENTION NOR HOSPITALIZATION WAS REQUIRED. THE SARA 3000 DEVICE INVOLVED IN THE EVENT IS AN ACTIVE RESIDENT LIFT. THIS MEANS THAT THE PATIENT IS INTENDED TO HAVE AN ACTIVE PARTICIPATION IN THE TRANSFER PROCESS - FROM RAISING THE PATIENT TO THE STANDING POSITION TO THE TRANSFER WITH THE LIFT. IN OTHER WORDS, THE INTENDED USER GROUP AS INDICATED IN THE DEVICE LABELLING, IS TO BE MENTALLY AND PHYSICALLY CAPABLE OF AT LEAST PARTIAL STANDING CAPABILITY AND STABILITY. IN ACCORDANCE TO THE INFORMATION PROVIDED, AT THE TIME OF INCIDENT THE RESIDENT WAS NOT BEARING HIS WEIGHT, SINCE HE CANNOT MOVE HIS FEET. WE CAN SUPPOSE THAT THE FACILITY STAFF WAS NOT AWARE ABOUT THE IMPORTANCE OF THE PROFESSIONAL PATIENT ASSESSMENT, WHICH SHOULD BE CARRIED OUT BY A QUALIFIED NURSE OR THERAPIST, BEFORE LIFTING PROCESS. IN RESULT, THE FACILITY STAFF WAS ASSESSED THE RESIDENT INCORRECTLY. IN THE LABELLING THERE IS A PARTICULAR ATTENTION TO THE RESPONSIBILITY OF THE DEVICE OWNER TO MAKE SURE THAT THE DEVICE USERS ARE TRAINED AND KNOWLEDGEABLE OF THE CONTENTS OF THE LABELLING. THE DEVICE INSTRUCTION FOR USE (IFU) KKX81010M-EN REV.3 CLEARLY STATES: "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." ADDITIONAL FACTOR WHICH CONTRIBUTES TO THE REPORTED INCIDENT WAS NOT USED THE BRAKES TO KEEP THE SARA 3000 IN PLACE. THE DEVICE INSTRUCTION FOR USE (IFU) KKX81010M-EN REV.3 CLEARLY STATES: "APPLY THE FOOT OPERATED REAR CASTOR BRAKES TO KEEP THE SARA 3000 IN POSITION." AFTER THE EVENT, THE DEVICE WAS PUT THROUGH A FUNCTION TEST AND NO DEVIATION WAS OBSERVED - THE DEVICE WAS IN FULL WORKING ORDER. FROM THIS IT APPEARS THE DEVICE WAS UP TO SPECIFICATION AT THE TIME OF THE INCIDENT, BUT IT WAS NOT USED CORRECTLY. THE INTENDED USE AND USE INSTRUCTIONS PER THE IFU INFORMS THE USER STEP BY STEP HOW THE LIFTING PROCEDURE SHALL BE PERFORMED. IN ADDITION, TRANSFER WITH USING SARA 3000 DEVICE SHALL ALWAYS BE PERFORMED UNDER SUPERVISION OF TRAINED PERSONNEL "SARA 3000 SHALL ALWAYS BE HANDLED BY A TRAINED CAREGIVER, CONTINUOUSLY ATTENDING TO THE RESIDENT, AND IN ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THESE OPERATING AND PRODUCT CARE INSTRUCTIONS." WHEN REVIEWING THE REPORTABLE EVENTS FOR SARA 3000 AND SIMILAR ACTIVE LIFTS, WE HAVE FOUND A NUMBER OF CASES RELATED TO THE FAILURE: PATIENT NOT SUITED FOR USE WITH THE DEVICE. THE OCCURRENCE RATE OF REPORTABLE COMPLAINTS WITH THIS FAULT DESCRIPTION IS RELATIVELY LOW. IN SUMMARY, THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT AND PLAYED A ROLE IN THE REPORTED INCIDENT. THERE WAS NO DEVICE DEFICIENCY FOUND AND FROM THAT PERSPECTIVE THE SYSTEM WAS UP TO SPECIFICATIONS AT THE TIME OF THE INCIDENT. WHEN THE IFU WOULD HAVE BEEN FOLLOWED AND THE PROFESSIONAL ASSESSMENT OF THE PATIENT BEFORE TRANSFER WOULD BE PROVIDED BEFORE TRANSFER, THE EVENT WOULD HAVE BEEN AVOIDED. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION, DUE TO THE POTENTIAL OF SERIOUS INJURY IF THE INCIDENT WOULD TO RECUR - THE PATIENT'S FALL. THIS PARTICULAR CUSTOMER SHOULD BE RE-TRAINED WITH THE INSTRUCTION ABOUT THE IMPORTANCE OF RESIDENT ASSESSMENT PRIOR EACH USE.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH RECEIVED THE CUSTOMER COMPLAINT RELATED TO SARA 3000 DEVICE. IT WAS REPORTED THAT THE DEVICE WAS POSITIONED IN FRONT OF THE PATIENT WHO WAS POSITIONED IN REGULAR WHEELCHAIR. PRIOR TO COMMENCING TO LIFTING PROCEDURE, THE LEGS OF THE DEVICE WERE OPENED AND BRAKES WERE NOT APPLIED, A SLING WAS NOT YET APPLIED TOO. WHEN THE RESIDENT STOOD UP AND TOOK BOTH HANDLES OF THE SARA 3000, HIS FEET WERE STILL ON THE GROUND (NOT POSITIONED YET ON THE FOOTPLATE OF THE SARA 3000). THE RESIDENT COULD NOT LIFT HIS FEET ANYMORE TO STAND ON SARA 3000 BASE AND HIS SHOE TRAPPED UNDER THE FOOTPLATE. THE PATIENT WANTED TO HELP TO FREE THE FOOT, BUT DUE TO HIS PHYSICAL CONDITION, HIS LEGS AND BODY WERE BEING OVERSTRETCHED (AS A RESULT OF A BIG PHYSICAL EFFORT) AND SUBSEQUENTLY PROPER POSITIONING OF THE LEGS WAS NOT POSSIBLE. THE RESIDENT WAS KEEPING HIS HANDS ON THE SARA 3000 LIFTING ARM. AS A CONSEQUENCE OF THAT, THE LIFTING DEVICE WAS MOVED FORWARD AND THE PATIENT FELL DOWN BACKWARDS. AS AN OUTCOME THE BRUISING ON THE PATIENT'S FOREHEAD WAS REPORTED. NEITHER MEDICAL INTERVENTION NOR HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211935 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH POLSKA SP Z O.O HEA0008

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other