MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

The (pma/510(k) number) k081047; k123188; k133786.This event has been recorded by zimmer biomet under cmp-(b)(4).A follow up medwatch will be submitted once the investigation is complete and a root cause has been established.

Event Description

It was reported that the ultra duo high fluid cart was leaking.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.It was reported from (b)(6) health center that a unit was leaking from the top of the cylinder.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 the unit was leaking from the top.He replaced the cl500 housing but noted that the unit was still leaking from the bottom and an exchange was required.The leaking was not covered by the warranty, and the work order was closed without resolution.The device was tested, inspected, and repaired.Service work order (b)(4) on 29 january 2018.The root cause for the unit leaking from the top of the cart was due to structural damage to the cl500 housing.The reported event was confirmed during inspection of the device, however the device was also found to be leaking from the bottom as well.The work order was then closed.A damaged cl500 housing would not properly seal in fluids that are added to the cylinder during use and as such would allow the fluid to leak out onto the top plate of the cart.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 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: 7265185
• MDR Text Key: 100009287
• Report Number: 0001954182-2018-00011
• 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: company representative
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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: 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
• Initial Date Manufacturer Received: 01/29/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1