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

Model Number N/A

Device Problems Device Emits Odor (1425); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during tech evaluation post surgery the unit was making a loud noise, and had a burning smell.There was some sparking while running the vacuum pump before removal, however, there was no harm.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected: b4, b5, d4, g4, g7, h2, h3, h4, h6, h8, h10.Device evaluations results/investigation findings: review of the most recent repair record determined the vacuum pump was not functioning properly and was loud and giving off a burning smell.The technician replaced the vacuum pump, tested the unit, and confirmed proper operation.Root cause: the vacuum pump is required to create suction in order for the unit to function as intended.Mechanical failure can occur within the vacuum pump assembly with either the pump failing to generate negative pressure, or with a failure of the carbon filter.Over time and with continuous use, the internal integrity of the vacuum pump can degrade and no longer be able to create the pressure needed for desired suction levels.Likewise, the carbon filter can back out of the assembly or over tighten, again causing suction failure.A mechanical failure of the component will cause an overall suction failure in the unit and will prompt vacuum sensor errors.Electrical failure can occur when the unit draws an excess of electrical current; this will cause the fuse for the vacuum pump to trip, denying the pump power and causing the component to fail and prompt vacuum sensor errors.Due to a range of external (non-design / non-manufacturing related) variables potentially impacting the component, identifying definitive causes for each vacuum pump failure is generally not possible.

Event Description

There is no additional information.

• Brand Name: DUO FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED POWERED SUCTION PUMP
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 10705222
• MDR Text Key: 213491655
• Report Number: 0001954182-2020-00040
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 00514010100
• Device Lot Number: 0025775
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1