BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA PLUS

    MDR report key: 2501472 · Received March 15, 2012

    Report

    Report Number
    3007420694-2012-00002
    Event Type
    Other
    Date Received
    March 15, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 16, 2012
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH (B)(4). THE ON-SITE EVALUATION OF THE DEVICE HAS BEEN CARRIED OUT BY AN ARJOHUNTLEIGH DILIGENT CLINICAL CONSULTANT, WHO IS A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, AND NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. IT WAS REPORTED THAT BOTH THE DEVICE AND SLING WERE IN GOOD CONDITION, AND THAT THE INCIDENT WAS CAUSED BY THE USER ERROR ACCORDING TO PATIENT AND MEDICAL CENTER EMPLOYEE STATEMENTS. PATIENT REPORTED THAT SHE HAD SPENT HOURS AT A PT SESSION BEFORE USING THE LIFTER AND WAS NOTICEABLE WEAKER THAN USUAL, PARTICULARLY IN HER LEGS AND UPPER BODY. ADDITIONALLY, THE FACILITY STATED THAT THE XL SIZE SLING HAD BEEN USED FOR APPROXIMATELY 2 - 3 WEEKS WITH THE PATIENT PREVIOUSLY WITHOUT INCIDENT; ACCORDING TO THE ARJOHUNTLEIGH CONSULTANT'S VISUAL OBSERVATION, AN L SIZE SLING SHOULD BE USED WITH THIS PATIENT. AFTER THE CONSULTANT'S OBSERVATION, THE FACILITY ADMITTED THAT THE XL SLING WAS USED BECAUSE THERE WAS NO L SLING READILY AVAILABLE. BASED UPON THE COURSE OF EVENTS REPORTED, THE INITIAL CAUSE OF COMPLAINT IS LACK OF A FULL CLINICAL ASSESSMENT OF THE RESIDENT'S CONDITION, AND THE EVENT MOST LIKELY OCCURRED AS A RESULT OF MISUSE. IF THE LEG STRAPS WERE INTENDED TO BE USED, THE PATIENT MUST BE ABLE TO PARTIALLY BEAR HER WEIGHT ACCORDING TO INSTRUCTION FOR USE (KKX52180M-EN.ISSUE_2) WHICH STATES: 'SARA PLUS IS INTENDED TO BE USED IN HOSPITALS, NURSING HOMES OR OTHER HEALTH CARE FACILITIES FOR THE DIFFERENT CATEGORIES OF RESIDENTS/PATIENTS, CATEGORY C, WHERE THE RESIDENT/PATIENT (...) IS ABLE TO PARTIALLY BEAR WEIGHT ON AT LEAST ONE LEG.' THE COMBINATION OF PATIENT'S WEAKENED STATE AND WRONG SIZED SLING USED RESULTED IN THE REPORTED EVENT OCCURRENCE. THE MANUFACTURER STRONGLY RECOMMENDS THAT THE FACILITY RE-TRAIN THEIR CAREGIVERS' INVOLVED WITH THE SLING AND LIFT DEVICES AGAINST THE PRODUCT LABELING AND INSTRUCTION FOR USE.

    Description of Event or Problem · 1

    WHILE CONDUCTING ROUTINE MONTHLY ROUNDS AT FACILITIES, THE ARJOHUNTLEIGH DILIGENT CLINICAL CONSULTANT SPOKE WITH A PATIENT AT ONE FACILITY, WHO REPORTED AN INCIDENT THAT HAD OCCURRED WHILE SHE WAS BEING TRANSPORTED TO THE TOILET IN A SARA PLUS. DURING TRANSPORTATION TO BATHROOM (WHILE IN A STANDING POSITION), HER RIGHT ARM SLIPPED OFF COMFORT ARC-REST AND BETWEEN SLING AND SHE BEGAN TO SLIP THROUGH THE SLING, FALLING TOWARDS THE FLOOR. SHE REPORTED THAT SHE HAD PREVIOUSLY SPENT HOURS AT A PT SESSION AND WAS NOTICEABLE WEAKER THAN USUAL, PARTICULARLY IN HER LEGS AND UPPER BODY. HER LEGS HAD BEEN SECURED ON THE FOOT SUPPORT WITH THE KNEE PAD VELCRO STRAP. IT WAS REPORTED BY CAREGIVER THAT AS THE PATIENT BEGAN TO FALL FROM THE LEFT, HER LOWER LEGS WERE CAUGHT IN THE STRAP CAUSING AN ABNORMAL POSITIONING OF HER LEGS. CAREGIVERS RELEASED THE STRAP AND LOWERED PATIENT TO THE FLOOR. PATIENT WAS MANUALLY RECOVERED FROM THE FLOOR TO BED BY A NURSE AND 2 THERAPIST STAFF MEMBERS WITH THE USE OF A BLANKET. PATIENT REPORTED TO THE ARJOHUNTLEIGH CONSULTANT THAT SHE HAD USED THE LIFT SINCE HER INCIDENT AND THAT THE LIFT WAS ALLOWED HER TO NOT HAVE TO USE THE BEDPAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA PLUS ACTIVE FLOOR LIFT FSA ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other