BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 6393688 · Received March 9, 2017

    Report

    Report Number
    3007420694-2017-00056
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    February 6, 2017
    Report Date
    May 10, 2017
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 WILL BE TRYING TO OBTAIN ADDITIONAL INFORMATION RELATING THE NEW FACT REVEALED BY THE FACILITY. WE WILL PROVIDE A FOLLOW-UP REPORT BASED ON DETAILS WE WILL RECEIVE.

    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). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE MEDIBO N.V (UNDER REGISTRATION #3004468271). AS OF 2011, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJOHUNTLEIGH, A BRANCH OF ARJO LIMITED MED AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #1000381138. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. THE ARJOHUNTLEIGH HAS BECOME AWARE OF THE CUSTOMER COMPLAINT ALLEGING THAT AFTER TOILETING PROCEDURE, USING SARA 3000 STANDING HOIST, THE PATIENT CANNOT KEEP HER BODY WEIGHT BALANCE AND SUBSEQUENTLY LOST THE INTENDED POSITION. FOLLOWING THE INFORMATION PROVIDED, "HER EYES ROLLED BACK IN HER HEAD AND SHE COLLAPSED". THERE WAS NO FALL, THE RESIDENT WAS ALL THE TIME SUPPORTED IN THE SLING. THE FACILITY STAFF WAS REPORTED TO CALL AN AMBULANCE AFTER RESIDENT WAS PUT SAFELY IN BED. AMBULANCE ARRIVED AND RESIDENT WAS TRANSPORTED TO HOSPITAL. AS A CONSEQUENCE, THE PATIENT SUFFERED A SERIOUS INJURY DESCRIBED AS BROKEN FEMUR. IN THE LIGHT OF REPORTED INFORMATION THE FOLLOWING FACTORS HAVE BEEN IDENTIFIED AS CONTRIBUTING TO THE REPORTED INCIDENT: 1. LACK OF FULLY ATTENTION OF THE RESIDENT PLEASE NOTE, THAT IF THE TRANSFER IS PERFORMED ACCORDING TO THE IFU WITH THE CONTINUOUSLY ATTENDING TO THE RESIDENT, THIS IS NOT LIKELY TO HURT ANY PATIENT. AS PER IFU KKX81010M REV. 3 "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." THE IFU INFORMS THE USER STEP BY STEP HOW THE LIFTING PROCEDURE SHALL BE PERFORMED. 2. THE PATIENT NOT SUITED FOR USE WITH THE DEVICE THE SARA 3000 DEVICE INVOLVED IN THE EVENT IS AN ACTIVE RESIDENT LIFT. THIS MEANS THAT THE PATIENT SHOULD BE 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 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 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." IN THE LIGHT OF REPORTED INFORMATION, IT SEEMS THAT THE USER WAS NOT SUITABLE TO USE THE SARA 3000 DEVICE BECAUSE THE PATIENT CANNOT KEEP HER BODY WEIGHT BALANCE AND SUBSEQUENTLY LOST THE INTENDED POSITION. PLEASE NOTE, THAT THE RESIDENT WAS ALL THE TIME SUPPORTED IN THE SLING. IT SEEMS MOST PROBABLE 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. IT WILL BE RECOMMENDED TO PERFORM RE-TRAINING WITH THE INSTRUCTION ABOUT THE IMPORTANCE OF RESIDENT ASSESSMENT PRIOR EACH USE. WHEN REVIEWING THE REPORTABLE EVENTS FOR SARA 3000 AND SIMILAR ACTIVE LIFTS, WE HAVE FOUND A LIMITED NUMBER OF CASES RELATED TO THE SIMILAR ISSUE: 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 MAY 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, THE EVENT WOULD HAVE BEEN AVOIDED.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH HAS BECOME AWARE OF THE CUSTOMER COMPLAINT ALLEGING THAT AFTER TOILETING PROCEDURE, USING SARA 3000 STANDING HOIST, THE PATIENT CANNOT KEEP HER BODY WEIGHT BALANCE AND SUBSEQUENTLY LOST THE INTENDED POSITION. FOLLOWING THE INFORMATION PROVIDED, "HER EYES ROLLED BACK IN HER HEAD AND SHE COLLAPSED". THERE WAS NO FALL, THE RESIDENT WAS ALL THE TIME SUPPORTED IN THE SLING. THE FACILITY STAFF WAS REPORTED TO CALL AN AMBULANCE AFTER RESIDENT WAS PUT SAFELY IN BED. AMBULANCE ARRIVED AND RESIDENT WAS TRANSPORTED TO HOSPITAL. AS A CONSEQUENCE, THE PATIENT SUFFERED A SERIOUS INJURY DESCRIBED AS BROKEN FEMURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175057 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO MEDICAL PRODUCTS NV HEA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Hospitalization