MAUDE Adverse Event Report: DORNOCH ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Pma 510(k): k081047; k123188; k133786.The device history record (dhr) review for ultra duo flex fluid cart noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2017, it was reported from community hospital that the unit was leaking.Account pulled the level sensor and found that the o-ring has failed.Account ordered the level sensor and they would replace it by themselves once received.Work order was closed.No repair checklist was required as per crm.The service technician never visited site to verify the reported event as the account ordered and replaced by account himself.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.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 the unit was leaking.The event occurred during cleaning but was first noticed during surgery.The cart also had a strange odor during the case, upon removing covers, evidence of bodily fluids leaking on to compressor and into bottom of cart was found.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE
• 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: 7183254
• MDR Text Key: 97756323
• Report Number: 0001954182-2018-00003
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2018

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: ULDU500SE
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1