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 Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product will be evaluated by an external contractor.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the ultra duo high fluid cart was not displaying fluid levels.Cylinder #1 read 639 and required replacement and #2 spiked from empty to fill and back to empty.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow up report is being submitted to report additional information.The previous repair report for ultra duo fluid system 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.On 29 october 2018, it was reported by university of iowa that the unit was not displaying fluid levels.Cylinder #1 read 639 and required replacement and #2 spiked from empty to fill and back to empty.Day mechanical systems, inc.Was contacted about the issue and service technician was dispatched to the site.On 29 october 2018, technician confirmed that the unit was not displaying fluid levels.So he replaced level sensor on both cylinders (part#91584) and verified that the unit was functioning as intended and return the unit back to service.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac rev.0.Service work (b)(4) on 29 october 2018.Based on the information, the root cause of the reported issue was due to a malfunctioning level sensor on both cylinders; which means the level sensor was not reading correct fluid levels or display.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the level sensors in both cylinders were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional information received.

• 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: 8020005
• MDR Text Key: 125666546
• Report Number: 0001954182-2018-00068
• 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
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1