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

Catalog Number UE514010100

Device Problem Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the unit shut down during surgery when there was only about 200ml of fluid in the cylinder.After they rebooted there was an alarm message saying that the cylinder was full.Both cylinders malfunctioned.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).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.Using crm to query for serial number (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical.On 12 june 2018, it was reported by (b)(6) hospital that the unit was shutting down during the operation only after filling 200ml and after rebooting the cart, he found that the unit was alarming that the unit was full.Silver reef biomedical services was contacted about the issue and service technician was dispatched to the site.On 12 june 2018, technician found that the unit was leaking from cylinder#2 and noticed that the unit was cracked bottom plate on cylinder#2.So he decided to exchange the carts.An exchange for the new cart was scheduled.A new cart was shipped from riverside to the facility.On 15 june 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 15 june 2018, the technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended 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.The cart was return to riverside for further evaluation.The investigation was performed on the cart and confirmed that the cracked bottom plate along drain port of cylinder #2.The service technician was unable to verify the reported issue.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 obtained throughout the follow-up process.

• Brand Name: DUO FLUID CART - REFURBISHED
• 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: 7745480
• MDR Text Key: 115913272
• Report Number: 0001954182-2018-00044
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UE514010100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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