MAUDE Adverse Event Report: DORNOCH ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number ULDU500R

Device Problem Inaccurate Information (4051)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The previous work order in customer relationship management (crm) for ultra duo flex fluid cart serial number (b)(4) (dms-27886-msfvlk) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 1 time, the previous repair being for reported evac comm errors on 2 february 2016.The reported event is not associated with the current repair.Thus, this repair was a non-related issue.On (b)(6) 2019, it was reported from (b)(6) that the cart was showing cylinders were full even though they were empty.On (b)(6) 2019, a zimmer biomet authorized 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 cylinder was reading the incorrect fluid levels.The technician replaced the level sensors in both cylinders (part #91584 and lot #0040109) 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 reported event of unit reporting that the cylinders were full when empty was due to defective level sensors.The level sensor reports the volume in the cylinder, and if it is defective it will not report a correct output, which can make the cylinders appear to be full when empty.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the 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.

Event Description

It was reported that ultraflex duo high fluid cart was showing cylinders were full even though they were empty.No adverse events were reported as a result of this malfunction.The event occurred during cleaning.There was no patient involvement.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
• 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: 8666832
• MDR Text Key: 147642796
• Report Number: 0001954182-2019-00037
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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