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

Catalog Number 00514010400

Device Problems Device Emits Odor (1425); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the unit had an odor coming from it and that it was hot to the touch.Unit was exhibiting a heat odor from the smell of pump oil heating up with no cooling fan.The event timing was post-surgery.There was no harm, no delay, and no medical intervention.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Reported event: on 07 november 2019, it was reported from (b)(6) hospital that an intellicart unit had an odor and was hot to the touch.Dhr and repair history review: the device history record (dhr) for intellicart system serial number (b)(4) was reviewed and 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.Device evaluations results/investigation findings: on 07 november 2019, it was reported from (b)(6) hospital that an intellicart unit had an odor and was hot to the touch.On 07 november 2019, replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed the issue; he found the cart had issued a high temperature alert.He checked the max temperature on the unit and verified it had reached 121f on 08 november 2019.Through testing he found the fan would fail to start sometimes.He replaced the fan (part #70096 and lot code #0024703) and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac.Service work order (b)(4) on 07 november 2019.Probable cause/root cause: the root cause for the unit having an odor and being hot was due to a failed cooling fan.The fan is meant to run when the vacuum pump turns on to keep the component from heating up to the point of excessive temperature.The fan intermittently working would result in the reported issues.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the fan kit was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may require additional actions.

Event Description

No additional event information was received.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 9317558
• MDR Text Key: 197774550
• Report Number: 0001954182-2019-00075
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010400
• Device Lot Number: 0041001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1