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

Model Number N/A

Device Problem No Device Output (1435)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Evaluation and investigation is in process.Once the investigation is complete, a supplemental medwatch will be filed.Evaluated by external contractor.

Event Description

It was reported that the unit was broken and was displaying incorrect fluid amounts on both cylinders.The event timing was after surgery cleaning.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

The previous repair record for intellicart system 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 record 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 4 times, the previous repair being for vacuum pump, control board, and the installation of an iv pole clamp on 04 june 2019.The control board is associated with the current repair.Thus, this repair was a related issue.On 18 june 2019, it was reported from (b)(6) hospital that an intellicart unit was broken and not displaying level.Follow up indicated that the incorrect fluid amount was displayed.On 18 june 2019, a replite technician was onsite for a wellness visit when he noted that the level sensors were not reading fluid levels correctly.The technician replaced the control board (part #70064 and lot code #0040388) 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.Service work order (b)(4) on 18 june 2019.Based on the information available, the root cause of the unit displaying incorrect fluid levels was due to a malfunctioning control board.The control board is the effective brain of the cart and oversees its electrical functions; a malfunctioning control board could cause the level sensors to read incorrect fluid levels.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the control board was 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

No additional event 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
• MDR Report Key: 8759880
• MDR Text Key: 150007996
• Report Number: 0001954182-2019-00044
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024466005
• UDI-Public: (01)00889024466005
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• 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: 00514010200
• Device Lot Number: 0026114
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1