MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number ULDU500

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that prior to surgery the unit was giving intermittent tandem warnings even when not in use.There was no patient involvement.No adverse event was reported due to 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, g4, g5, g7, h1, h2, h3, h4, h6, h10.Device evaluations results/investigation findings: on dec 20, 2019 the technician reviewed this unit and confirmed the tandem warning concerns for both cylinders.He also noted that the a/d value for cylinder 1 was reading 627.He replaced both the cylinder 1 level sensor and cylinder 2 sensor.He noted no further concerns with the unit 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.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.Valve pack failures are a well-known failure mode, with no allegations of harm or injury to a patient.This complaint will be tracked and trended.Complaint trending procedure for any adverse trends that may warrant further action.

Event Description

It was reported that prior to surgery the unit was giving intermittent tandem warnings even when not in use and did not result in any harm or delay.The tandem warnings were going off right before the cleaning cycle right before they plugged in the cart for cleaning.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 9586523
• MDR Text Key: 194601319
• Report Number: 0001954182-2020-00003
• 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: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1