MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O. O. DVT THIGH GARMENTS; JOW

Model Number DVT30S

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2015 arjohuntleigh received a customer complaint where it was reported that while performing an orthopedic surgery utilizing the dvt30/s compression garment it was noticed that the sleeve tubing coupling had failed, pulling the tubing apart, and interrupting the flowtron compression therapy being delivered during the procedure.Doctor was manipulating the patients operative limb where the dvt30/s was placed and this moves the sleeve tubing which then comes apart from the tubing connector.The tubing was plugged back in by or personnel and repeatedly disconnected.This occurred in no less than 3 procedures.It was suggested that the issue put the patient at risk of developing dvt.No injuries were sustained by the patient.

Manufacturer Narrative

An investigation was carried out into this complaint.Based on the information gathered during the orthopedic surgery utilizing the dvt 30s sterile compression garment and the pump, the garment tube disconnected from the connector interrupting the patient's therapy.No injuries were received as a consequence.Review of reportable complaints for dvt garments showed that there are no related events.Therefore, the complaint described above seems to be an isolated event to date.It can be established that the dvt prevention system (consisting of acs900 pump and flowtron dvt30s sterile thigh garment) was being used for patient handling at the time of the event.No malfunctions were indicated regarding the acs900 pump.Nevertheless, dvt30s sterile thigh garment was found to have not been to specification when the event took place as parts tube and connector were found to be easily to disconnect.Therefore, the system was found to work not as intended.Flowtron dvt30s sterile thigh garments from the manufacturer stock were verified.The following results were observed: tubes and connectors were measured and were found to be in specification.Four samples were taken to measure the force needed to disconnect parts (tube and connector).Required force was not specified, however test results did not confirmed that it is easy to separate parts after assembling process (average force was 137 n).The same test has been performed on 4 samples assembled 1 month before - test results were not conclusive force was higher or lower.Dvt30s garments manufactured in july 2015 which were stored in us warehouse were returned to arjohuntleigh for investigation.Based on the evaluation performed, we were able to confirm the reported issue.Following the above evaluation and all test results, it appears more likely that the issue of parts (tube and connector) disconnection can be caused by deforming of tube after some time.Nevertheless, we cannot threat this as certainty based on tests conducted to date.To solve the issue in the quickest way a new design solution was proposed replacing the current connector for a different one.As the current design of connector showed that its surface is very smooth and flat it was decided to implement a new different shape of connector called "christmas tree connector".After reviewing all information provided it was determined that this claimed issue did not cause or contribute to death, serious injury or medical intervention to prevent harm.Designated complaint handlers have reported the issue to authorities, but this was done in the abundance of caution.However after our evaluation performed, it comes forward that disconnection of tube and connector causes air leakage and activates visual and audible low pressure alarm in the pump allowing the user to easily detect the failure.Following the risk assessment and taking into account mitigation factors, it can be considered that the risk for the patient is very low and we no longer consider this complaint to be reportable.

• Brand Name: DVT THIGH GARMENTS
• Type of Device: JOW
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ks. piotra wawrzyniaka 2; komorniki, PL62- 052; PL PL62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O. O.; ks. piotra wawrzyniaka 2; komorniki, PL62- 052; PL PL62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore,; ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5366810
• MDR Text Key: 36474694
• Report Number: 3007420694-2016-00005
• Device Sequence Number: 1
• Product Code: JOW
• 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,health
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/04/2016,12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DVT30S
• Device Lot Number: Z011 16/06/15 20:29
• 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: 03/04/2016
• Distributor Facility Aware Date: 12/16/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other