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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the cart was giving valve pack errors during cleaning.The cart was also leaking from the top in manual cleaning mode without manifolds.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.Device evaluations results/investigation findings: customer stated that the cart was giving valve pack errors.No additional information was available.Technician verified the valve pack errors.He was able to move the valve pack in service mode and free them up.He ran several wash cycles without issue.Tested all functions and returned the cart to service.Root cause: valve pack failure can result from a multitude of events, ranging from mechanical failure, electrical failure, and use error.Valve pack failure can result in the population of valve pack errors, drain errors, slow draining or a complete inability to process fluid, a leak, or an overflow of fluid.The valve pack is required to rotate and lock into the vane sensors in order for the unit to function.Failure to rotate can cause an error to populate, stemming from the aforementioned potential failure modes such as a clog, electrical failure of the valve pack board or sensor, a mechanical failure of the motor, chain, or gear, or a valve failure.A clog due to biomaterial or a foreign object will cause a blockage in the valve pack, causing difficulty draining or impairing the valve pack from rotating to find the appropriate vane sensor.An electrical malfunction can cause the valve pack board or sensor to fail, prompting errors in the system.Continuous use can result in wear on the mechanical components in the valve pack, which will cause a loss of function of the motor, chain, gear, or valve pack as a whole.Due to a range of external (non-design / non-manufacturing related) variables potentially impacting the component, identifying definitive causes for each valve pack failure is generally not possible.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 for any adverse trends that may warrant further action.

Event Description

There is no additional information.

• Brand Name: ULTRA QUAD 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: 10302237
• MDR Text Key: 199692583
• Report Number: 0001954182-2020-00030
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K081047
• 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: 08/11/2020

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: ULQD500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1