MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; 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 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product evaluated by external contractor.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The device history record (dhr) review for intellicart system serial number (b)(4), noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.The device was noted to have not been previously repaired by zimmer biomet surgical.On (b)(6) 2017, it was reported from (b)(6) that the unit was leaking fluid.Pm medical was contacted about the unit and dispatched a service technician to be at the site.On (b)(6) 2017, the technician found that the unit was issuing drain error and performed the backflush to resolve the drain error.While performing the backflush, he noted that the unit was leaking fluid from the receiver and suspected the leaking was due to back pressure.He performed a full soak cycle and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.While the service technician confirmed the reported event and the device was noted to be functioning as intended after a full soak was performed, it is unknown with the information provided as to what actually caused the leaking from cart.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR
• 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: 7186086
• MDR Text Key: 97399668
• Report Number: 0001954182-2018-00004
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK162421
• 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: 01/19/2018

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: 00514010200
• Device Lot Number: 0025013
• Other Device ID Number: (01) 00889024466005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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