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 Inaccurate Information (4051)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Malfunctioning level sensor.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 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.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) that the cylinders are reading full, but are in fact empty.On (b)(6) 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.On (b)(6) 2019, the technician arrived at the site and confirmed that the cart was giving incorrect fluid level readings and alarming.The technician replaced the level sensor (part #91584 and lot code #0029256) 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.The root cause for the cylinder reading incorrectly was due to a malfunctioning level sensor.The level sensor reads fluid levels in the cylinder, but can give erroneous readings when malfunctioning.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the level sensor was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Product evaluated by external contractor.

Event Description

It was reported that the cylinders are reading full, but are in fact empty.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
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8851313
• MDR Text Key: 207032177
• Report Number: 0001954182-2019-00047
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1