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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

• Brand Name: ULTRAFLEX DUO HIGH 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: 7679606
• MDR Text Key: 114022984
• Report Number: 1954182-2018-00042
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULDU500SE
• Device Lot Number: 0022762
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1