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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the unit was leaking fluid from the bottom of the cart.The event timing was unknown.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.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.Using view 09-23 from the etq reliance system, there was 01 complaint that contained part number: 00514010200, lot# 0023953 and complaint description with ¿leaking¿.The keyword of ¿leaking¿ was chosen as a filter based upon the reported failure of ¿the unit was leaking fluid from the bottom of the cart.¿ using view 09-23 from the etq reliance system, there was 24 complaints that contained part number: 00514010200, complaint description with the keyword: ¿leaking¿ the keyword of ¿leaking¿ was chosen as a filter based upon the reported failure of ¿the unit was leaking fluid from the bottom of the cart.¿ on (b)(6) 2017, it was reported from (b)(6) hospital that the unit was leaking from the bottom of the cart.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 that the bottom plate of the unit was cracked.So the exchange was initiated.An exchange for the new cart was scheduled.A new cart (sn#(b)(4)) was shipped from (b)(6) to the facility (shipping#(b)(4)).On 26 oct 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 28 nov 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 13 dec 2017.Upon follow from the riverside, it was confirmed that unit will be refurbished service work order (b)(4) on 23 nov 2017.The root cause of the fluid leak from the bottom of the cart 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 WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE
• 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: 6997581
• MDR Text Key: 91952791
• Report Number: 0001954182-2017-00034
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• 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: 00514010200
• Device Lot Number: 0026114
• Other Device ID Number: (01) 00889024466005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• 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