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 Problems Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During cleaning it was reported that the cart was giving level sensor errors for both cylinders, as well as displaying incorrect information for fluid volume in both cylinders.There was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Dhr review: the previous repair report for ultra duo flex fluid cart serial number (b)(4) 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.Evaluation of device: on 5 november 2019, a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived at the site and confirmed that the cart was giving level sensor range errors for both cylinders.The technician replaced the level sensors for each cylinder (part #91584 and lot # 0026756, 0025972) and found that the issue persisted.The technician then replaced the unit control board (part #91940 and lot #0040943) and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.Probable/root cause: the root cause for the reported event that the unit was issuing level sensor range errors was due to a defective control board.The control board designates the flow of electric current to the designated components, such as the level sensor.The level sensor measures the volume of fluid in the cylinder, and when defective can provide the incorrect or no output.A defective control board prevents the flow of current to the level sensor, and therefore prevents the unit from reporting the correct fluid levels.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the control board and level sensors were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).This complaint will be tracked and trended.Complaint trending procedure for any adverse trends that may warrant further action.

Event Description

No additional event information.

• 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: 9483944
• MDR Text Key: 199703276
• Report Number: 0001954182-2019-00083
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K133786
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500
• Device Lot Number: 0020103
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1