MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 00514010200

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

Duo fluid cart started smoking during surgery.There was no harm or delay involved in the event, and an alternate device was used.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

(b)(4).The device history record (dhr) for intellicart system serial number (b)(4) was reviewed 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.The reported event was confirmed by the service technician who performed the repair.On 17 october 2018, it was reported from (b)(6) hospital that a cart was smoking during surgery and that it would not power back up.Replite was contacted about the cart and dispatched a service technician to be at the site.On 18 october 2018, the service technician arrived at the site and inspected the device.He was unable to reproduce the power issue, but found that the vacuum hose was resting on the vacuum pump, causing it to give off a burning smell.He tied the vacuum hose away from the vacuum pump and then verified that the cart was functioning as intended.The cart was then returned to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 17 october 2018.The cause of the cart producing smoke was due to the vacuum hose coming in contact with the vacuum pump.When the cart is being used to suction fluid, the vacuum pump is in constant use and heats up.The vacuum hose is made up of a softer plastic that when exposed to heat would burn and produce both a burning smell and smoke.If the vacuum hose would come into contact with the vacuum pump during use, it can cause the hose to melt and produce smoke.While the vacuum hose was found to have been on the vacuum pump, it is unknown how the vacuum hose was able to come into contact with the vacuum pump.In addition, the technician was unable to reproduce the power issue with the device.Therefore, based on the information provided, a specific root cause of the reported issues cannot be determine.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 information available.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8021033
• MDR Text Key: 125670972
• Report Number: 0001954182-2018-00067
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010200
• Device Lot Number: 0025730
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• 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