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

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by the facility that a resident suffered a laceration on their leg due to the leg strap on the sara 3000.This had occurred back in may, there are no records of this by sales, service, or qa.On (b)(6) 2015 (b)(6) - facility representative, called and reported that the laceration on the patient's leg did require sutures.She stated that the straps were put in wrong and twisted and while moving the resident she became combative and the twisted strap lacerated her leg.

Manufacturer Narrative

An investigation was performed on this complaint.Arjohuntleigh received a complaint where it was indicated that as the consequence of using the leg fixation belt accessory of sara 3000, the resident suffered a skin laceration that required some sutures.It was reported that at the time of the incident, the belt that supported the resident's lower calves was positioned incorrectly, in a twisted position.Additionally, the behavior of the patient was assessed as "combative".When reviewing similar reportable events for sara 3000 devices and its predecessor, we have not found any case with the similar fault description compared to the one investigated here: the lower leg strap accessory causing the skin injury.According to that this event is considered as a single event.When the event occurred the device was used for treatment of a person, and therefore it played a role in the event.Since despite our best efforts there is no information or indication of any defect, it is assumed that no device failure occurred.From that we (arjohuntleigh) conclude that our device met the manufacturer specification requirements during the time of the issue.Based on the collected information and findings made during re-creation of the event in the laboratory condition, we (arjohuntleigh) have been able to establish that the lower leg strap accessory does not present any risk for user's skin.Additionally upon the course of the investigation, the following was concluded: the position of the lower leg strap belt has no impact of the outcome of the investigation.The incorrect, twisted position of the knee support belt might have influence on the patient comfort.No consequences / injuries observed on person's skin.The position of the strap buckle has no impact of the outcome of the investigation.When the buckle is locked into the strap socket, there is no contact with the patient's body.When the buckle is not applied and under some circumstances are exposed on the user's body, there is no immediate risk found.The buckle does not have any sharp edges.The movement of the user legs have no impact of the outcome of the investigation.Even when the volunteer was moving the legs in the uncontrolled directions, no issue occurred.To sum up, the test results could not re-create the outcome of this customer complaint and event description.It seems that the reported skin laceration, could have only occurred as the result of additional off-label use, such as not correctly evaluating if the patient is suitable for being transferred with this device.Examples of such issues could be a condition of extremely frail skin or a pre-existing patient's leg injury.Following our simulation test, it would appear any injuries would only be considered likely when not following the labelled instructions of how to apply the knee strap, and in addition not taking into consideration if a person is suited for transfer with the device, also as required by the labelling (combativeness, skin condition, pre-existing injuries, etc).In conclusion the device was found to be to specification, it was being used for patient transfer, according to our investigation in a way that is likely to have been without following the instructions for use.As a result the device contributed to the outcome of the event, namely a skin injury on the lower legs.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. Z O.O.; ks. piotra wawrzynika 2; komorniki 62052 ; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5003238
• MDR Text Key: 23153570
• Report Number: 3007420694-2015-00150
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Followup
• Report Date: 09/14/2015

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: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2015
• Distributor Facility Aware Date: 07/14/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/11/2015
• Date Manufacturer Received: 07/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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