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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under cmp-(b)(4).(b)(4).Customer has indicated that the product is in process of being returned to an external contractor for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the unit was leaking.The event timing was unknown.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

The previous repair report for ultra duo flex cart unit was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for the device was noted to have been previously repaired five times, the previous repair being for a level sensor issue on (b)(6) 2016.The level sensor issue was not associated with the current reported issue, so the previous repair was a non-related issue.On (b)(6) 2017, the service technician from (b)(4) was at (b)(6) and found that the unit had a leaking seal.On (b)(6) 2018, he replaced the manifold housing with a housing kit (part# 91927) 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 as per cl ¿ repair carts rev.4.While the service technician does confirm the reported event and notes that the device was functioning as intended after the cl500 housing was replaced, it is unknown if the customer used the out of round manifolds with their device or what factors contributed to the cl housing leaking.Therefore, based on the information provided, a specific root cause of the cracked manifold housing cannot be determined.

• Brand Name: ULTRA DUO HIGH FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE
• 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: 7149159
• MDR Text Key: 96029827
• Report Number: 0001954182-2017-00043
• 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: 01/25/2018

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: 12/11/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2013
• 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