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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2018

Event Type  malfunction  

Manufacturer Narrative

Current leakage problem would stand for the carbon filter leaking.This complaint is being reported by zimmer biomet as (b)(4).The previous repair report for intellicart system 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.Uhs was contacted about the unit and dispatched the service technician to be at the site.The technician noted that there was a follow up call made and it was clarified that the unit was having low suction on the cylinder #1.He also found that the carbon filter was leaking carbon and vacuum regulator was failing.The technician replaced the carbon filter along with a vacuum regulator and 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.The root cause of the shutting off in the cylinder #1 was due to a carbon filter and vacuum regulator failing.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the carbon filter and vacuum regulator was replaced.Whenever the exhaust filter was failing or clogged, it will disrupt the air flow of the vacuum pump; which prevent vacuum pump from creating a negative pressure and subsequently makes the pump to shut off.A malfunctioning regulator would prevent the cart from maintaining the feedback loop between the control board and the regulator system on that vacuum line, therefore not allowing the cart to maintain the suction level through one side of the vacuum line.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 is reported the duo cart was shutting off in the middle of a surgery.During repair of the duo cart, the service technician clarified that the unit was having low suction on the cylinder #1.He found that the carbon filter was leaking carbon and vacuum regulator was failing.No adverse events have been reported as a result of this malfunction.

• 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
• 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: 7328007
• MDR Text Key: 102102255
• Report Number: 0001954182-2018-00018
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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: 00514010200
• Device Lot Number: 0023916
• Other Device ID Number: (01)00889024466005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1