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 Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous work order in customer relationship management (crm) for ultra duo flex fluid cart 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 work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed.On 14 november 2018, it was reported from (b)(6) that a unit had a fluid leak.On 14 november 2018, (b)(4) was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that the unit did have a fluid leak.The technician noted that caps were being used in place of manifolds which was causing the leaking.The technician used the instructed manifolds (per the ifu) 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.Service work order (b)(4) on 14 november 2018.Based on the information provided, the root cause of the unit leaking was due to the account using a manifold lid and not using the entire manifold assembly when processing carts.The zimmer biomet transposal ultra evacuation technical manual states on page 9 to verify that all reservoirs have green lids/manifolds and that all of the ports are capped.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 had a fluid leak.The event occurred during cleaning.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: 8293866
• MDR Text Key: 134724661
• Report Number: 0001954182-2019-00011
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2019

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 Catalogue Number: ULDU500
• Device Lot Number: 0021659
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2016
• 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