SARA 3000
Report
- Report Number
- 3007420694-2016-00191
- Event Type
- Injury
- Date Received
- September 1, 2016
- Date of Event
- August 3, 2016
- Report Date
- August 4, 2016
- Manufacturer
- ARJOHUNTLEIGH POLSKA SP. Z O.O.
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). CORRECTION: PLEASE NOTE THAT SECTION B4, B5, F6, G4 HAVE BEEN CORRECTED ACCORDING TO THE INFORMATION PROVIDED. ADDITIONAL MANUFCTURER NARRATIVE: AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. BASED ON THE INFORMATION RECEIVED, IT APPEARS MOST LIKELY THAT DURING THE TRANSFER USING SARA 3000 ACTIVE LIFT WITH SLING THE PATIENT LET GO OF THE HANDLES OF THE LIFT WITHOUT THE SLING BEING CORRECTLY APPLIED AND FELL AS A CONSEQUENCE. THE RESIDENT WAS BEING LOWERED WHEN THE EVENT OCCURED. MOBILITY OF THE PATIENT REMAINS UNKNOWN. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR GENERAL FAULT DESCRIPTION (SLIP OUT OF SLING). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE LOW AND SLIGHTLY DECREASING. IT CAN BE ESTABLISHED THAT THE LIFT AND THE SLING, WHICH WORK TOGETHER AS A SYSTEM, WERE BEING USED FOR PATIENT CARE WHEN THE EVENT TOOK PLACE, AND AS SUCH IT APPEARS THE SYSTEM PLAYED A ROLE IN THE EVENT OUTCOME. THERE ARE NO INDICATIONS THAT ANY PART OF THE LIFT DEVICE NOR THE SLING FAILED OR OTHERWISE CONTRIBUTED IN A WAY THAT IS FOUND SIGNIFICANT FOR THIS INVESTIGATION. BASED ON THIS, IT WAS ESTABLISHED THAT THE SYSTEM (LIFT AND SLING) WAS FOUND TO HAVE BEEN UP TO SPECIFICATION, WHEN THE EVENT TOOK A PLACE. FROM OUR INVESTIGATION, INCLUDING A SIMULATION, IT COMES FORWARD THAT WHEN THE LABELLING IS FOLLOWED AND THE SLING IS PLACED IN THE CORRECT WAY AND THE INSTRUCTIONS OF USING THE SYSTEM IS FOLLOWED, THERE IS NO LIKELINESS OF A PATIENT DROP OR OTHER ADVERSE EVENT DURING THE TRANSFER OF THE PATIENT WITH THE SLING. EVEN IF THE PATIENT WERE TO HAVE THEIR HANDS LET GO OF THE DEVICE ARMS THEY WOULD STILL BE SUPPORTED BY THE SLING. A PATIENT DROP COULD TAKE A PLACE WHEN A SEQUENCE OF MULTIPLE USE ERRORS OCCURS (AT MINIMUM): THE PERSON'S ARMS ARE PLACED NOT OUTSIDE THE SLING; THE PERSON WAS NOT CORRECTLY EVALUATED PRIOR TO THE TRANSFER; THE CHEST STRAP IS NOT APPLIED OR APPLIED BUT VERY LOOSELY (DOES NOT ADHERE TO THE PATIENT AS RECOMMENDED IN SLING INSTRUCTION FOR USE). WITH THE ABOVE CONSIDERATIONS, AND WHEN COMPARED TO THE INFORMATION RECEIVED, IT WAS CONCLUDED THAT THE MOST LIKELY CAUSE OF THE EVENT IS THAT THE PATIENT WAS NOT BEING CORRECTLY EVALUATED BEFORE TRANSFER (BY A QUALIFIED NURSE OR THERAPIST) AND ADDITIONALLY THE IFU WAS NOT FOLLOWED ON SEVERAL POINTS (MULTIPLE USE ERRORS), ALLOWING THE PERSON TO SLIP OUT OF THE SLING. THE CURRENT SLING INSTRUCTIONS FOR USE (IFU) INCLUDES IMPORTANT INFORMATION CONCERNING PROPER AND SAFE USE OF THE SYSTEM (SLING AND LIFT TOGETHER): 1) "THE ACTIVE SLING IS INTENDED TO THE PATIENT/RESIDENT WHO HAS BEEN CLINICALLY ASSESSED TO CORRESPOND TO THE FOLLOWING CATEGORIES: SITS IN A WHEELCHAIR, IS ABLE TO PARTIALLY BEAR WEIGHT ON AT LEAST ONE LEG, HAS SOME TRUNK STABILITY, DEPENDENT ON CARER IN MOST SITUATIONS, PHYSICALLY DEMANDING FOR CARER, STIMULATION OF REMAINING ABILITIES IS IMPORTANT. THE RIGHT TYPE AND SIZE OF SLING SHOULD BE USED AFTER PROPER ASSESSMENT OF EACH RESIDENT'S SIZE, CONDITION AND THE TYPE OF LIFTING SITUATION. IF THE PATIENT/RESIDENT DOES NOT MEET THESE CRITERIA AN ALTERNATIVE EQUIPMENT/SYSTEM SHALL BE USED". 2) "WARNING: TO AVOID INJURY, ALWAYS ASSESS THE RESIDENT PRIOR TO USE" PLEASE NOTE THAT THE CUSTOMER WAS INTERVIEWED BY AN ARJOHUNTLEIGH REPRESENTATIVE BUT COULD NOT PROVIDE ANY TRAINING DATES FOR STAFF; THE DEVICE LABELING REQUIRES THAT ALL USERS MUST BE TRAINED AS PER THE IFU. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO EVALUATE THE PERSON TO BE TRANSFERRED, BEFORE EACH TRANSFER AND PROPER LIFT AND SLING INSPECTION BEFORE TRANSFER. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. ARJOHUNTLEIGH FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.
ON (B)(6) 2016 ARJOHUNTLEIGH RECEIVED THE CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE PATIENT'S TRANSFER USING SARA 3000 ACTIVE LIFT, RESIDENT SLID THROUGH THE SLING AND SUFFERED A BROKEN CLAVICLE. IT WAS REPORTED THAT RESIDENT NEEDED TO BE REMOVED FROM TOILET. LIFT WAS ALREADY IN PLACE FROM PUTTING RESIDENT ON TOILET. SLING WAS ATTACHED TO LIFT AND AROUND PATIENTS BODY, THE BUCKLES ON THE SLING WERE NOT ATTACHED WHILE RESIDENT WAS USING TOILET. THE CAREGIVER ATTACHED THE BUCKLES AND RAISED LIFT TO REMOVE RESIDENT FROM TOILET. THE CAREGIVER TRIED TO WIPE RESIDENT BUT COULD NET GET BEHIND HER SO SHE PULLED THE LIFT AWAY FROM TOILET TO GAIN ACCESS TO RESIDENTS. WHILE MOVING RESIDENT TO WIPE HER IT WAS NOTICED THAT RESIDENT PASSED OUT, AS A CONSEQUENCES CAREGIVER TRIED TO RELOCATE RESIDENT TO THE BED AND STARTED TO LOWER LIFT. THE RESIDENT SLID THROUGH THE SLING AND SUSTAINED A BROKEN RIGHT CLAVICLE.
ON 04 AUGUST 2016 ARJOHUNTLEIGH RECEIVED THE CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE PATIENT'S TRANSFER USING SARA 3000 ACTIVE LIFT, RESIDENT SLID THROUGH THE SLING AND SUFFERED A BROKEN CLAVICLE. IT WAS REPORTED THAT RESIDENT NEEDED TO BE REMOVED FROM TOILET. LIFT WAS ALREADY IN PLACE FROM PUTTING RESIDENT ON TOILET. SLING WAS ATTACHED TO LIFT AND AROUND PATIENTS BODY, THE BUCKLES ON THE SLING WERE NOT ATTACHED WHILE RESIDENT WAS USING TOILET. THE CAREGIVER ATTACHED THE BUCKLES AND RAISED LIFT TO REMOVE RESIDENT FROM TOILET. THE CAREGIVER TRIED TO WIPE RESIDENT BUT COULD NET GET BEHIND HER SO SHE PULLED THE LIFT AWAY FROM TOILET TO GAIN ACCESS TO RESIDENTS. WHILE MOVING RESIDENT TO WIPE HER IT WAS NOTICED THAT RESIDENT PASSED OUT, AS A CONSEQUENCES CAREGIVER TRIED TO RELOCATE RESIDENT TO THE BED AND STARTED TO LOWER LIFT. THE RESIDENT SLID THROUGH THE SLING AND SUSTAINED A BROKEN RIGHT CLAVICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574018 | SARA 3000 | SARA 3000 | FSA | ARJOHUNTLEIGH POLSKA SP. Z O.O. | HEA0002-US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization |