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

Model Number N/A

Device Problem Fluid Leak (1250)

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

Event Date 07/02/2018

Event Type  Malfunction  

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4). Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Duo fluid cart was leaking fluid out of cylinder one event occurred during surgery.

• 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
• 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: 7660413
• MDR Text Key: 113397086
• Report Number: 0001954182-2018-00041
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,USER F

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/03/2018
• 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: 0027215
• OTHER Device ID Number: (01)00889024465992
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 02/14/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A