MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. SARA 3000

Model Number HEA0002

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Bone Fracture(s) (1870)

Event Date 01/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

Event Description

It was reported by the customer representative that before a transfer with the sara 3000 standing aid, a resident set on the edge of the bed, put his feet on the foot support of the lifter and caregiver tried to attach the leg support strap to secure the legs of the patient.Suddenly the resident removed his leg from the lifter and twisted it.

Manufacturer Narrative

(b)(4).It was reported to arjohuntleigh some time after the event that while a caregiver was attending to secure the resident's leg on the sara 3000 foot plate platform, a patient's feet slipped off the foot plate support.The event outcome was indicated to be a fracture of the left leg and as a consequence the patient required hospitalization.When reviewing similar reportable events for sara 3000 devices, we have found a number of cases related to this type of event: a patient not suited for use with the device.The occurrence rate of a reportable complaint with this event description is relatively low.When the event occurred, the device was used for treatment of a person, it played a role in the event.After the event, the device was put through a function test and no deviation was observed - the device was in full working order.From this it appears the device was up to specification at the time of the incident.In accordance to the information provided, the resident's leg slipped off the foot plate platform while she was sitting on the bed.It means that at the time of incident the resident was not bearing her weight.There was also no slipping of her body out of the supporting sling reported.Please note that as per sara 3000 device design, the foot plate platform is inserted a few centimeters above the floor, parallel to it.Therefore, to slip the feet from the foot plate surface, the patient would need to have removed her feet on her own accord.The outcome of the issue, indicated as a leg fracture would also indicate that the leg movement was unexpected.Based on our best product knowledge it was concluded to be very unlikely that the patient will have fractures from the lifting system even if the patient's feet slip off the foot plate support.Therefore the most common and likely root cause for this event is that the patient could have additional health issues prior to the lift usage which could lead to the fractures in easy way - eg.Severe osteoporosis.Based on the above, our findings appears to point to the facility staff not knowing or otherwise understanding of the necessity of the professional assessment of the patient before transfer as indicated in the instruction for use (ifu), which in turn makes it unlikely the professional judgment of the patient was followed.Our evaluation appears to be in line with an use error having occurred: our assumption is that the facility staff does not understand the importance of the patient assessment which should be carried out by a qualified nurse or therapist before lifting process.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.When the ifu would have been followed and the professional assessment of the patient before transfer would be provided before transfer, the event would have been avoided.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.We find this complaint to be reportable to the competent authorities.

• Brand Name: SARA 3000
• Type of Device: SARA 3000
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. piotra wawrzyniaka 2; komomiki PL-62 052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5003236
• MDR Text Key: 23154891
• Report Number: 3007420694-2015-00153
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Report Date: 08/11/2015,08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: HEA0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2015
• Distributor Facility Aware Date: 07/21/2015
• Device Age: 5 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/11/2015
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 71