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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Duo fluid cart was leaking fluid out of cylinder one event occurred during surgery.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.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 jul 2, 2018, it was reported from beth israel deaconess that the unit was leaking fluid out of cylinder #1.Replite was contacted about the cart and dispatched a service technician to be at the site.On jul 3, 2018, the technician confirmed that this cart has a cracked bottom plate.Exchange paperwork was created and submitted.No repair checklist was required as per crm.An exchange for the new cart was scheduled.A new cart (serial number: (b)(4)) was shipped from riverside to the hospital.On jul 2, 2018, the new cart was confirmed to have been delivered to the hospital and replite was dispatched a service technician to the site to perform exchange.On jul 13, 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 device was tested and inspected without any installation checklist as per crm.The technician then repackaged the new cart so that it returned to service without further incident.The exchanged cart was picked up from the hospital.The exchange cart was confirmed to have been returned to riverside on jul 16, 2018 and the unit was refurbished.A notification of defect was created for crack at the drain port of the bottom plate for intellicart and scn was issued as outcome of nd to improve parameter for the injected molding process that would improve the knit line strength of the bottom plate which was implemented on 24 april 2017.Since the issue is still existed with all the units that are manufactured after the implementation date.An action is issued to address these bottom plate cracks along the drain port of the intellicart units.While the service technician confirmed the reported event and the issue was resolved with an exchange, it is unknown with the information provided how the bottom plate cracked.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.There are actions associated with the bottom plate cracking along the drain port, but it cannot be determined if this type of failure is related to the reported event.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, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 7660413
• MDR Text Key: 113397086
• Report Number: 0001954182-2018-00041
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: P 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: 07/19/2018

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 Model Number: N/A
• Device Catalogue Number: 00514010100
• Device Lot Number: 0027215
• Other Device ID Number: (01)00889024465992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1