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U.S. Department of Health and Human Services

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

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010200
Device Problem Smoking
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.

 
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Brand NameDUO FLUID CART WITH SMOKE EVACUATOR
Type of DeviceAPPARATUS, 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 Key8021033
Report Number0001954182-2018-00067
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010200
Device LOT Number0025730
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/22/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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