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U.S. Department of Health and Human Services

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

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DORNOCH ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problem Fluid Leak
Event Date 06/26/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Pma 510(k): k081047; k123188; k133786. The device was evaluated by an external contractor. The previous repair report for ultra duo flex fluid cart, serial number (b)(4, was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair. The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed. Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 1 time, the previous repair being for evac comm errors on 26 january 2018. The receiver issue was not associated with the current repair service, so the previous repair was a non-related issue. On (b)(6) 2018, it was reported from (b)(6) that the unit is leaking fluid out bottom of cart during case. Moore's electrical & mechanical construction, inc was contacted about the cart and dispatched a service technician to be at the site. The technician arrived at the site on jun 27, 2018 and confirmed that the unit was leaking as he found that the unit was leaking from 90 elbow below condensation tube. He replaced teflon tape and tightened fitting and during testing the unit on full soak, unit is leaking from vent valve on valve pack. The technician then replaced the valve pack (part # 70017 and lot code#0027755) and the cooling fan (part # 91936 and lot code#0026545). He then verified that the cart was functioning as intended. The technician then returned the cart to service without further incident. The device was tested, inspected, and repaired. Service work order (b)(4) on jun 26, 2018. The root cause of the reported event was due to damaged 90 degree elbow on the condensation tube and bad vent valve on the valve pack of the unit. If the 90 degree elbow is damaged or the vent valve on the valve pack is malfunctioned it can allow fluid to escape from the damaged openings and cause a leak. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the teflon tape, valve pack and fan kit were replaced. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

 
Event Description

It was reported that unit is leaking fluid out bottom of cart during surgery. There was no harm and no delay. An alternate device was used to complete the surgery. No adverse events were reported as a result of this malfunction.

 
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Brand NameULTRAFLEX DUO HIGH 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 Key7679606
Report Number1954182-2018-00042
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 07/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberULDU500SE
Device LOT Number0022762
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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