MAUDE Adverse Event Report: DORNOCH DUO FLUID CART; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number 00514010100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).K081047; k123188; k133786.The product will be evaluated by an external contractor.Once the evaluaion/investigation has been completed, a follow up mdr will be submitted.Product evaluated by external contractor.

Event Description

It was reported the cart's fluid was leaking from the bottom.The reported issue was noticed after surgery and it was confirmed that there was fluid exposure in or.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury.The initial report was forwarded in error and should be voided.

• Brand Name: DUO FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 7139377
• MDR Text Key: 95800144
• Report Number: 0001954182-2017-00046
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010100
• Device Lot Number: 0025012
• Other Device ID Number: (01)00889024465992
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1