BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLITES (BOXES OF 10), LOOP & CLIP

    MDR report key: 8284638 · Received January 29, 2019

    Report

    Report Number
    3012292104-2019-00005
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Report Date
    April 10, 2019
    Manufacturer
    GETINGE DOMINICAN REPUBLIC SA
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO THE ARJO REPRESENTATIVE THAT THERE WAS THE INCIDENT WITH THE INVOLVEMENT OF THE FLITE LOOP SLING AND NON-ARJO MEDICAL DEVICE - LIKO LIFT. IT WAS STATED THAT DURING TRANSFER, JUST ABOVE THE BED, THE SLING RIPPED AT THE STITCHING. THE RESIDENT WAS APPROXIMATELY 2 INCHES ABOVE THE MATTRESS WHEN THE CAREGIVER NOTICED THE FAILURE. THE PATIENT WAS SAFELY PUT BACK INTO THE BED AND THERE WAS NO FALL OR INJURY REPORTED. AFTER THE EVENT IT WAS DECIDED TO THE RETURN THE CLAIMED SLING TO THE MANUFACTURER (DOMINICAN REPUBLIC) FOR A FURTHER EVALUATION. THE FLITE IN QUESTION WAS RETURNED TO THE MANUFACTURER TO THE DOMINICAN REPUBLIC FOR FURTHER INVESTIGATION. IT WAS STATED THAT NEITHER EVENTS NOR NON-CONFORMANCES WERE FOUND PERFORMING THE TESTS AND DURING THE INVESTIGATION. MANUFACTURING DETAILS FOR THE SLING IN QUESTION (FLITE LOOP SLING (S/N DED1301593) WAS BEING CHECKED DURING QUALITY INSPECTION GATE TO VERIFY THE REQUIRED PRODUCT SPECIFICATIONS AND CHECK WHETHER THE ACCEPTANCE PERFORMANCE CRITERIA WERE MET. RECORDS OF THE INSPECTION ARE DOCUMENTED IN THE DEVICE HISTORY RECORD (DHR). THE DEVICE HISTORY RECORD HAS BEEN REVIEWED FOR THIS SPECIFIC DEVICE AND NO ANOMALY WAS FOUND. FOLLOWING VALUATION OF THE RETURNED PRODUCTS AND TESTING PERFORMED AT THE MANUFACTURING SITE THE FOLLOWING HAVE BEEN ESTABLISHED: - VISUAL INSPECTION RESULTS - ALL DIMENSIONS WERE BETWEEN SPECIFICATION LIMITS ACCORDING TO THE CURRENT "REQUIREMENTS FOR FLITES VISUAL INSPECTION", ACCORDING TO INTERNAL MANUFACTURER TESTING INSTRUCTIONS. - LOAD TEST RIG - IT WAS CONFIRMED THAT CALIBRATION RECORDS FOR MEASUREMENT EQUIPMENT USED DURING THE QUALITY CHECK RELEASE WERE IN COMPLIANCE AND ALL TESTED PIECES PASSED THE LOAD TEST WITH SATISFACTORY RESULTS. - LINE CLEARANCE PROCESS - IT WAS PERFORMED ACCORDING TO THE ARJO INTERNAL PROCEDURE WITH SATISFACTORY RESULTS DURING THE MANUFACTURING PROCESS. - MATERIAL USED - BILL OF MATERIAL AND LOT NUMBER OF MATERIAL USED IN THE WORK ORDER MANUFACTURING PROCESS WERE REVIEWED AND ALL RAW MATERIAL WAS PROPERLY INSPECTED IN THE INCOMING PROCESS, WITH NO EVIDENCE THAT COULD LEAD TO THE FAILURE MODE. - PERSONNEL AND MACHINES - STAFF WERE PROPERLY TRAINED AND WITH THE SUFFICIENT EXPERIENCE; EQUIPMENT BELONGING TO THE SEWING MACHINE LINE WAS MAINTAINED IN THE ESTABLISHED TIMEFRAME. DEFECTS PER MILLION WERE CALCULATED. THE DEFECT RATE PER MILLION IS EQUAL TO 0.02%. SIGMA LEVEL CALCULATOR BASED ON NUMBER OF DEFECTS AND TOTAL NUMBER OF OPPORTUNITIES CALCULATED RISK VALUE AS 1 REPRESENTING A LOW RISK FOR THE PATIENT. BASED ON PROVIDED TEST REPORT IT CAN BE CONFIRMED THAT INTERNAL MANUFACTURING PROCESS COULD NOT CONTRIBUTE TO THE CAUSE OF THE EVENT. NO DEVIATIONS (LIKE MANUFACTURING ENVIRONMENT, EMPLOYEES MISTAKE, FAILURE OF EQUIPMENT USED DURING FLITE SEWING PROCESS) IN MANUFACTURING PROCESS WERE FOUND. BASED ON THE PRODUCT KNOWLEDGE THE DAMAGED OF THE ACCESSORY COULD BE CAUSED BY CATCHING IN AN OBSTRUCTION, AND SUBSEQUENTLY MATERIAL RIPPED DUE TO THE APPLICATION OF OUTSIDE FORCE. IT'S WORTH TO EMPHASIZE THAT INSTRUCTION FOR USE (04.SL.00-INT1_3) FOR THE LOOP SLING PROVIDES PATIENT WITH LIFTING PROCEDURES: "IF AN ADJUSTMENT IS NEEDED, LOWER THE RESIDENT AND MAKE SURE THAT THE WEIGHT OF THE RESIDENT IS TAKEN UP BY THE RECEIVING SURFACE BEFORE REMOVING THE LOOPS." "MAKE SURE STRAPS ARE NOT CAUGHT BY WHEELCHAIR OR LIFT CASTORS." IN THIS CASE, DESPITE OUR BEST EFFORTS, WE CANNOT DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THE EVENT. PLEASE NOTE, IF THE CAREGIVERS FOLLOW ALL RECOMMENDATIONS AND PROCEDURES PROVIDED IN INSTRUCTIONS FOR USE AND THE SLING IS NOT SUBJECTED TO AN ADDITIONAL, EXTERNAL EXCESSIVE FORCE THE RISK OF SERIOUS INJURIES AND HAZARD SITUATIONS IS LOW. TO CONCLUDE, ARJO DISPOSABLE SLING WAS USED FOR PATIENT'S TRANSFER AND IN THAT WAY CONTRIBUTED TO THE ALLEGED EVENT. THERE WAS A FLITE LOOP SLING DEFICIENCY FOUND (LOOP FAILURE) AND FROM THAT PERSPECTIVE THE SYSTEM DID NOT MEET THE MANUFACTURER'S SPECIFICATION AT THE TIME OF THE EVENT. WE DECIDED TO REPORT THIS EVENT TO COMPETENT AUTHORITY DUE TO THE RISK OF INJURY IF THE PRODUCT BREAKS DURING USE AND THE PATIENT FALLS DOWN ON THE FLOOR.

    Additional Manufacturer Narrative · 0

    THE CLAIMED SLING WILL BE SENT TO THE MANUFACTURER FOR THE FURTHER EVALUATION. THE CONCLUSION WILL BE PROVIDED UPON THE INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2018019 BY THE MANUFACTURER GETINGE DOMINICAN REPUBLIC SA (REGISTRATION#3012292104) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE TRANSFER LOOP SLING TORE AT THE SEAM. THE SLING HAD ONLY BEEN USED TWICE AND HAD NO VISIBLE SIGN OF DAMAGE. THE SLING WAS BEING USED WITH A NON-ARJO LIFT. THE PATIENT WAS APPROXIMATELY 2 INCHES ABOVE THE BED WHEN THE CAREGIVER NOTICED THE RIP. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79845 FLITES (BOXES OF 10), LOOP & CLIP LIFT, PATIENT, NON-AC-POWERED FSA GETINGE DOMINICAN REPUBLIC SA MFA2000-L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other