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

Catalog Number 00514010200

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that unit was leaking from bottom of cart.The event occurred during surgery.There was no harm and no delay.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).The previous repair report for intellicart system serial number (b)(4), was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired once times, the previous repair being for a window tint issue on 07 may 2018.The window tint issue was not associated with the current reported issue, so the previous repair was non-related issue.On 05 july 2018, it was reported by (b)(6) hospital that the unit was leaking from the bottom.Replite was contacted about the issue and service technician was dispatched to the site.On 05 july 2018, technician found that the unit had cracked bottom plate.An exchange for the new cart was scheduled.A new cart (sn# (b)(4)) was shipped from riverside to the facility (shipping #: (b)(4)).On 09 july 2018, the new cart was confirmed to have been delivered to the facility and service company was dispatched a service technician to the site to perform exchange.On 10 july 2018, the technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended as per cl-install carts rev 08 and placed the cart into service without further incident.The technician then repackaged the old cart so that it returned to service center.The exchanged cart was picked up from the facility.The exchange cart was confirmed to have been returned on 20 july 2018 and it was refurbished as sn# (b)(4).The cart was return to riverside for further evaluation.The investigation was performed on the cart and confirmed that the cart had cracked bottom plate at the cylinder#1 drain port.Service work order (b)(4) on 05 july 2018.Notification of defect riv-2017-0005 was created for the cylinder bottom plate fracturing along the knit line at the drain port of the bottom plate for intellicart.Scn (scn-riv-17-002) was implemented on 24 april 2017 as an outcome of this notification of defect and was to improve the injected molding process to better support the strength of the knit line.Since the scn was issued, however, it has been found that the cylinder bottom plate can still fracture along the knit line of the drain port.Processes were issued to further address this bottom plate crack along the drain port on the intellicart.Based on the information, the root cause of the reported issue was due to a cracked bottom plate at cylinder drain port; which allows fluid to leak.The reported event was confirmed during inspection of the device.This issue was resolved by exchanging the carts.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• 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: 7745462
• MDR Text Key: 115904343
• Report Number: 0001954182-2018-00050
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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 Catalogue Number: 00514010200
• Device Lot Number: 0026318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1