MARISA
Report
- Report Number
- 3007420694-2016-00179
- Event Type
- Death
- Date Received
- August 16, 2016
- Report Date
- July 21, 2016
- Manufacturer
- ARJO MED. AB LTD.
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO ED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9611530 OR MEDIBO (MEDIBO MEDICAL PRODUCTS NV / 3004468271) AND AH MAGOG (ARJOHUNTLEIGH MAGOG, INC. / 9681684). 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. 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). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO ED. AB LTD (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #9611530 OR MEDIBO (MEDIBO MEDICAL PRODUCTS NV / 3004468271) AND AH MAGOG (ARJOHUNTLEIGH MAGOG, INC. / 9681684). 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. 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). INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. IT APPEARS THAT DURING A RESIDENT TRANSFER FROM BED TO CHAIR ONE OF THE LEG SLING CLIPS CAME LOOSE FROM THE SPREADER BAR OF THE MARISA LIFT AND THE RESIDENT SLID OUT OF THE SLING FALLING ON THE FLOOR. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (FAILURE MODE: CLIP DETACHMENT). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE LOW AND STABLE. BASED ON THE PHOTOGRAPHIC EVIDENCE, IT WAS INDICATED THAT THE SLING INVOLVED TO BE FITTED WITH "GREY" CLIPS. PRODUCTION OF SLINGS WITH GREY CLIPS HAS STOPPED SOME TIME AGO (BETWEEN 2005 2006). FOLLOWING THE LIFT INSTRUCTION FOR USE (IFU) FOR THESE ITEMS THE SLING SHOULD BE DISCARDED AFTER TWO YEARS LIFETIME, OR BEFORE THAT, WHEN DAMAGED. THE SLING INVOLVED THEREFORE WAS SIGNIFICANTLY PAST ITS LIFETIME. THIS IS AN INDICATION THAT THE SLING SHOULD HAVE BEEN WITHDRAWN FROM USE AND REPLACED, AND ALSO INDICATES THAT THE IFU WAS NOT BEING FOLLOWED. ADDITIONALLY, IT WAS FOUND THAT CLIPS INSERTS HAD POPPED OUT AND THEREFORE CAN BE SEEN AS HAVING BEEN DAMAGED. ALTHOUGH WE DO NOT BELIEVE THIS PLAYED A SIGNIFICANT ROLE IN THE EVENT BY ITSELF, THESE ARE INDICATION THAT THE SLING SHOULD HAVE BEEN WITHDRAWN FROM USE AND REPLACED, AND ALSO INDICATES THAT THE IFU WAS NOT BEING FOLLOWED. ACCORDING TO THE ABOVE THE SLING AND THE LIFT WHICH WORK TOGETHER AS A SYSTEM WERE FOUND TO HAVE NOT BEEN TO SPECIFICATION WHEN THE EVENT TOOK A PLACE. IT CAN BE ESTABLISHED THAT THE SLING AND THE LIFT WERE BEING USED FOR PATIENT HANDLING BUT IT APPEARS IT CONTRIBUTED TO THE EVENT POSSIBLY DUE TO A USE ERROR. A SLING CLIP, ONCE CORRECTLY ATTACHED AND MONITORED TO STAY IN PLACE AS THE WEIGHT OF THE PERSON IN THE SLING IS GRADUALLY TAKEN UP, AS INDICATED TO BE REQUIRED IN THE LABELLING, IS LOCKED IN POSITION WITH THE WEIGHT OF THE PATIENT. IT IS NOT LIKELY TO COME OFF DURING ON LABEL USE. BASED ON PRODUCT KNOWLEDGE AND PREVIOUSLY MADE SIMULATIONS THIS THEN LEAVES OPEN A POSSIBLE SEQUENCES OF EVENTS: 1) FOLLOWING ALL DETAILS REPORTED THE PATIENT WAS LIFTED FROM THE BED, THEREFORE FROM THE HORIZONTAL POSITION. FROM SIMULATIONS, WE KNOW THAT A PERSON CAN BE LIFTED FROM A HORIZONTAL POSITION WITH ONE OF THE LEG CLIPS NOT IN PLACE. HOWEVER, TYPICALLY WHEN THE PATIENT IS AT THE END OF THAT TRANSFER, PUT INTO A MORE UPRIGHT, SEATED POSITION BEFORE LOWERING TO A WHEELCHAIR, THE WEIGHT SHIFTS TOWARDS THE MISSING CLIP STRAP AND THE PERSON FALLS OUT. FOLLOWING THE ABOVE SCENARIO, IT WOULD APPEAR POSSIBLE THAT ONE OF THE CLIPS WAS NOT IN PLACE AT THE START OF THE LIFTING PROCEDURE (IT COULD HAVE BECOME WIGGLED OFF BEFORE BEING LIFTED FROM BED) AND WHEN THE WEIGHT WOULD SHIFT AS THE PATIENT WAS PUT INTO A MORE UPRIGHT, VERTICAL POSITION THE PERSON WOULD SLIDE OUT, WHICH MIGHT HAVE LOOKED LIKE TWO CLIPS HAVING COME UNDONE WHILE THERE WAS ONLY ONE ALREADY UNDONE. 2) THERE ARE ADDITIONAL SCENARIOS THAT ALSO INVOLVE USE THAT IS NOT FOLLOWING THE IFU: WHEN A TRANSFER OCCURS FROM A BED, THIS MEANS AT SOME POINT THERE MUST BE A REPOSITIONING FROM HORIZONTAL TO SEATED POSITION. THIS THEN MEANS THAT THE RESIDENT MUST BE TURNED IN THE CORRECT DIRECTION. AS A RESULT THE CAREGIVER MUST MANIPULATE THE SPREADER BAR THAT HOLDS THE SLING AND IS ABLE TO TURN FOR THIS PURPOSE. THE INTENDED AND LABELLED USE IS THAT THIS OCCURS BY OPERATING AND MANIPULATING THE SPREADER BAR ITSELF, AND NOT THE SLING NOR THE PERSON IN THE SLING. IF THIS LABELLING IS FOLLOWED THERE CAN BE NO ISSUE. HOWEVER, IT IS POSSIBLE FOR THE CAREGIVER TO NOT HAVE FOLLOWED THE LABELLING AND HAVE USED THE PERSON IN THE SLING TO MANIPULATE THE SPREADER BAR. IN THIS CASE THE CLIP COULD BE INADVERTENTLY PULLED OFF BY THE CAREGIVER WHILE USING THE SLING OR THE PERSON IN THE SLING FOR REPOSITIONING. THE INSTRUCTIONS FOR USE (IFU) FOR LIFT INDICATES: "WARNING: IMPORTANT: ALWAYS CHECK THAT ALL THE SLING ATTACHMENT CLIPS ARE FULLY IN POSITION BEFORE AND DURING THE LIFTING CYCLE, AND IN TENSION AS THE PATIENT'S WEIGHT IS GRADUALLY TAKEN UP." FROM THIS EVALUATION IT WOULD APPEAR MOST LIKELY THAT THE EVENT WAS CAUSED BY THE USER NOT FOLLOWING THE IFU, DUE TO LACK OF AWARENESS OF THE IFU CONTENTS. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO CORRECT LIFTING PROCEDURE. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.
ARJOHUNTLEIGH HAS BEEN INFORMED ABOUT SERIOUS INJURY RESULTING IN A FATALITY OCCURRING AFTER A CLIP BROKE ON THE SLING OF A MARISA LIFT.
ON 21 JULY 2016 ARJOHUNTLEIGH HAS BEEN INFORMED VIA NOTICE LETTER ABOUT SERIOUS INJURY RESULTING IN A FATALITY OCCURING AFTER A CLIP BROKE ON THE SLING OF A MARISA LIFT. BASED ON THE INFORMATION RECEIVED, WE CAN STATE THAT DURING THE PATIENT'S TRANSFER ONE OF CLIPS OF THE SLING DETACHED FROM THE LUGS OF THE LIFT SPREADER BAR AND THE RESIDENT FELL ON THE FLOOR. TAKING INTO ACCOUNT THE PHOTOS PROVIDED, WE CAN STATE THAT SLING INVOLVED WAS FITTED WITH GREY CLIPS. ADDITIONALLY, IT WAS FOUND THAT CLIPS INSERTS HAD POPPED OUT AND THEREFORE CAN BE SEEN AS HAVING BEEN DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532384 | MARISA | FSA | FSA | ARJO MED. AB LTD. | KGA0200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Death |