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

Catalog Number 00514010200

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Overfill (2404)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is in process of being evaluated by an external contractor and the investigation is in process.Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the unit was out of service.The device was tagged out of service with a note reading "do not use -top loose".The cart was overfilled and caused incorrect readings on both cylinders and would not drain.The event occurred after surgery.There was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Udi#: (b)(4).The device history record (dhr) for intellicart system serial number (b)(4) was reviewed 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.Using crm to query for serial number (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical.On 24 apr 2019, it was reported from (b)(6) hospital that the unit was out of service.On 25 apr 2019, a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site.The technician arrived and found that the user had overfilled the cart and level sensors were showing "0" even though fluid was present in both cylinders.He proceeded to connect spare level sensor, but the monitor still read "0".He replaced the intellicart control board (part# 70064, lot code 0029820) and level sensor read properly.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac rev.0.The root cause for the reported event was due to a malfunctioning control board.When a control board fails, it can prevent the cart from functioning properly.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the control board was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information available.

• 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
• MDR Report Key: 8561557
• MDR Text Key: 145284482
• Report Number: 0001954182-2019-00031
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010200
• Device Lot Number: 0024393
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1