MAUDE Adverse Event Report: DORNOCH DUO FLUID CART; APPARATUS, SUCTION

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

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 was leaking during procedure.The event occurred during surgery.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 fluid 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 (b)(6) 2017, it was reported from (b)(6) that the unit was leaking.The service company was contacted about the cart and dispatched a service technician to be at the site.On (b)(6) 2017, the technician found crack on the bottom plate.So the exchange was initiated.An exchange for the new cart was scheduled.A new cart was shipped from riverside to the facility (shipping# (b)(4)).On (b)(6) 2017, 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 (b)(6) 2017, 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 15 nov 2017 and it was refurbished without any further evaluation as noted in zpm (b)(4) a return equipment log.The root cause of the leaking issue was due to a crack on the bottom plate.The reported event was confirmed during inspection of the device and it was resolved by exchanging the cart.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
• Type of Device: APPARATUS, SUCTION
• 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: 7071457
• MDR Text Key: 94080975
• Report Number: 0001954182-2017-00040
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P K162421
• 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: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• 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: 00514010100
• Device Lot Number: 0026114
• Other Device ID Number: (01)00889024465992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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