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 Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Connection Problem (2900)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation is complete, a follow up/final report will be submitted.Device evaluated by manufacturer? evaluated by external contractor.

Event Description

It was reported that this unit is giving inaccurate volume readings on both cylinders, and having connection issues with the evac during cleaning.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information available.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Device evaluations results/investigation findings: the technician confirmed that the unit was getting range errors for both level sensors.The technician did not find any issues with connecting to the evac.The level sensors were replaced.The unit was tested to verify proper operation and returned to service root cause: the level sensor is required to read and report fluid level in the cylinders in order for the unit to function as intended.Design-related failure modes: a clog due to biomaterial or a foreign object will cause a blockage in the cylinder and impaired use of the drain; this failure will cause inaccurate readings from the level sensor, as the residual fluid unable to drain may not be accurately accounted for by the component.Mechanical failure from loosening can occur as the level sensor is mounted in the base of the cart with an o-ring and held in place with two setscrews.Over time and through continuous use, the screws can loosen, allowing the sensor rod to move within the cylinder and prompting errors.The level sensor float can fail through continuous use and wear as well.Bioburden can build up on the level sensor float or magnet, or the level sensor float could crack, both failure modes can disrupt the buoyancy of the float, causing incorrect fluid level readings.Application-based failure modes: tandem and range errors occur due to user error.Tandem errors populate when the device¿s software detects an incorrect fluid level measurement in one or both cylinders often when the user introduces fluid into the cylinder after the pump has shut off due to the cylinder being full.Tandem errors are a result of fluid levels increasing without the vacuum system being turned on.Due to a range of external (non-design / non-manufacturing related) variables potentially impacting the component, identifying definitive causes for each level sensor failure is generally not possible.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time.Level sensor failures are a well-known failure mode, with no allegations of harm or injury to a patient.This complaint will be tracked and trended for any adverse trends that may warrant further action.

• 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
• MDR Report Key: 11293492
• MDR Text Key: 230757077
• Report Number: 0001954182-2021-00002
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K123188
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• 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: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1