MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 3000 TOURNIQUET W/HOSES AND LOP SENSOR; TOURNIQUET, PNEUMATIC

Catalog Number 60300010100

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the unit had res leak alarm.Red side reservoir cuff is leaking, indicating there is a leak present between the pump and the valves.There was leakage from the port at about 1 lpm.Event occurred during surgery , no harm, no delay reported.It is unknown whether there was any spontaneous deflation.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.On (b)(6) 2018, it was reported that the unit had a res leak alarm.The red side reservoir cuff is leaking, indicating there is a leak present between the pump and the valves.There was leakage from the port at about 1 lpm.The customer returned an a.T.S.3000 tourniquet device, serial number (b)(4), for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation, change notices or any other issues with manufacturing or with the device.The dhr review also found that all verifications, inspections and tests were successfully completed.Zimmer biomet surgical has not previously repaired/evaluated a.T.S.3000ts tourniquet serial number (b)(4) as documented in the repair reports in livelink.Product review of the a.T.S.3000 tourniquet on november 21, 2018 revealed that the main cuff reservoir leak was due to a bad inflate clippard valve.The control panel was broken out of the front housing.The display had a bright spot in the center.The limb occlusion pressure (lop) reference cards and rear housing attention label was damaged.Repair of the a.T.S.3000 tourniquet was performed by zimmer biomet surgical on november 21, 2018 which included replacement of the front housing, on/standby button, alarm silence button, display assembly, control panel, clippard valve, lop reference card, and labels.A.T.S.3000 tourniquet, serial number (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The reported event was confirmed since during product review there was a main cuff reservoir leak due to a bad inflate clippard valve.The cause of the res leak alarm was due to the bad inflate clippard valve.The root cause of the res leak alarm could not be determined with the provided information since it is unknown how the clippard valve became damaged.The issue was resolved with the replaced clippard valve.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information was received.

• Brand Name: A.T.S. 3000 TOURNIQUET W/HOSES AND LOP SENSOR
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 8101241
• MDR Text Key: 128273168
• Report Number: 0001526350-2018-01045
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• PMA/PMN Number: K050411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60300010100
• Device Lot Number: 61919683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1