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 Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Duo fluid cart was leaking blood like fluid from the bottom during surgery.No patient consequences were reported as a part of this event.There was no delay in the surgery.

Event Description

N/a.

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).This medwatch has been initially incorrectly reported.This medwatch is being submitted as a correction as this event should not have been reported.

• 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: 7803088
• MDR Text Key: 117833849
• Report Number: 0001954182-2018-00057
• 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
• Type of Report: Initial,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1