MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART; APPARATUS, SUCTION, WARD USE, PORTABLE

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).G5 (pma no): k081047; k123188; k133786.Once the investigation has been completed, a follow up mdr will be submitted.Will be evaluated by external contractor.

Event Description

It was reported that the unit was leaking around the cylinder between the top plate and the bottom plate on the right side.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history record (dhr) for ultra duo flex fluid cart was reviewed and 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.The device was noted to have not been previously repaired by zimmer biomet surgical.Replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that both cylinders were leaking air at the cl-500 housing.He replaced the cl-500 housing and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.The device was tested, inspected, and repaired.The root cause for the unit leaking around the cylinders between the top plate and bottom plate was due to a defective cl-500 housing.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the cl-500 housing was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: ULTRA DUO HIGH FLUID CART
• 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: 7149155
• MDR Text Key: 96051926
• Report Number: 0001954182-2017-00041
• 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,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• 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: ULDU500
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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