MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE

Catalog Number ULDU500

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).On (b)(6) 2019, it was reported from (b)(6) hospital that unit was leaking fluid from both right and left manifold housings.The zimmer biomet authorized service technician from (b)(4) arrived at the site on 01 july 2019, evaluated the unit and confirmed the reported event.After that he replaced manifold housings and confirmed that the unit was functioning as intended.The service technician then returned the unit back to service without any further concerns.The unit was tested, inspected, and repaired.While the service technician confirmed the reported event and the device was noted to be functioning as intended after the cl 500 housing were replaced on both the cylinders of cart, it is unknown with the information as why there was a leak from the cl500 housing.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.Product evaluated by external contractor.

Event Description

It was reported that the unit was leaking fluid from both right and left manifold housings.The event occurred during cleaning.There was no harm or delay reported.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: ULTRA DUO HIGH FLUID CART
• 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: 8755728
• MDR Text Key: 200012395
• Report Number: 0001954182-2019-00043
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123188
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ULDU500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2013
• 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