MAUDE Adverse Event Report: DORNOCH DUO FLUID CART; APPARATUS, SUCTION

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the unit appeared to be leaking from the left side.The event timing was unknown.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) 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.A service technician was dispatched to be at the site.The technician arrived at the site and confirmed that water was leaking from the overflow tube.The technician lowered the water pressure on the evac and then verified that the cart was functioning as intended.The technician then returned the evac to service without further incident.The device was tested, inspected, and repaired.The root cause for the unit leaking from the left side was due to excessive water pressure on the evac causing fluid to leak from the overflow tube during processing.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the water pressure was lowered.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Evaluated by external contractor.

• Brand Name: DUO FLUID CART
• Type of Device: APPARATUS, SUCTION
• 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: 7150706
• MDR Text Key: 96026396
• Report Number: 0001954182-2017-00048
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK162421
• 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: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: 00514010100
• Device Lot Number: 0023838
• Other Device ID Number: (01) 00889024465992
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2017
• 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