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 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).K081047; k123188; k133786.The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the unit was leaking fluid from the bottom.The event occurred during surgery.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).No functional defect was found with the device during evaluation, therefore, the complaint will be processed using icwr0008 rev.1.As such, no device history record and complaint history review are required for the complaint.Using crm to query for serial number (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical.On 04 june 2018, it was reported from community hospital south that a unit was leaking fluid from the bottom during.Lmc service solutions was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and was unable to confirm the reported event and noted not issue with the cart.The device was tested, inspected, and repaired as per cl ¿ repair carts rev.4.Service work order (b)(4) on 04 june 2018.The reported event was never confirmed during inspection of the device and the device was noted to be functioning as intended.Therefore the root cause could not be determined.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
• MDR Report Key: 7579849
• MDR Text Key: 110457476
• Report Number: 0001954182-2018-00036
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• 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: 0027358
• Other Device ID Number: (01)00889024465992
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1