MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 4000TS LOANER; TOURNIQUET, PNEUMATIC

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The product has been received by zimmer biomet.A follow up medwatch will be submitted once the investigation is complete and a root cause has been established.Received; however, not yet evaluated.

Event Description

It is reported that surgeon set the pressure on the ats at 300 mmhg and blood was squirting through.The surgeon then adjusted the pressure to reflect 350 mmhg; however, the blood continued to squirt through in a pulsating manner.The patient had to be given 4 units of blood and the procedure took longer than intended due to the blood loss.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).It was reported that the pressure was at 300 mmhg and the blood was still squirting through.They then adjusted the pressure to 350 mmhg, which they felt should cut off the blood flow; however, the blood continued to squirt through in a pulsating manner.The tourniquet screen was not locked up during the case.The customer returned an a.T.S.4000 tourniquet device for evaluation.The device history record (dhr) review noted no related non-conformances, requests for deviation (rfd), change notices (cn) or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections and tests were successfully completed.Initial qa inspection of the a.T.S.4000 tourniquet on february 1, 2018 revealed that the device operated as intended.The device passed all testing and calibration with no findings.The device needed the software upgraded to the newest revision.Repair of the a.T.S.4000 tourniquet was performed by zimmer biomet surgical on february 1, 2018 which included upgrading the software to the latest revision.A.T.S.4000 tourniquet was then tested and functioned properly.It was repaired, inspected and tested per (b)(4).The reported event was non-verifiable since during the initial inspection it was noted that the device operated as intended.The root cause of the reported event could not be specifically determined with the information that was provided.During the initial inspection it was noted that the device operated as intended.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: A.T.S. 4000TS LOANER
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7290613
• MDR Text Key: 100758449
• Report Number: 0001526350-2018-00166
• Device Sequence Number: 1
• Product Code: KCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 60400010100
• Device Lot Number: 63574787
• Other Device ID Number: (01) 00889024376731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1