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

Catalog Number 00514010100

Device Problem Device Emits Odor (1425)

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

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Report source: (b)(6).Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the unit had a burning odor.Additionally, the cart is not powering on the iv pole is fully extended.The event occurred during surgery.Follow up is currently being conducted for additional information on the event.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).On 12 september 2019, it was reported from canada - mcmaster hospital that an intellicart unit had a burning odor, was not powering on, and its iv pole was stuck fully extended.The device history record (dhr) for intellicart system serial number (b)(4) was reviewed 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.On 12 september 2019, it was reported from canada - mcmaster hospital that an intellicart unit had a burning odor, was not powering on, and its iv pole was stuck fully extended.On 12 september 2019, customer service ¿ canada was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed the unit was not powering on, finding a blown fuse in the power inlet module.He replaced the power inlet module fuses (part #90562) and confirmed the unit would then power on.He also confirmed that the power iv pole was not traveling, and the odor was coming from the iv pole motor failing.He also found one of the hooks for the iv pole was missing.Finally, he found that a connector on the receiver had broken free.He returned on 25 september 2019 and replaced the power iv pole (part #00-5140-120-00), the iv pole hook (part #91757), the receiver (part #part #70055 and lot code #0041266), and the control board (part #70064 and lot code #0041471) and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 12 september 2019.The root cause of the unit having a burning odor was due to the iv pole motor failing.The iv pole motor controls the speed at which the iv pole is raised and lowered; the motor failing but continuing to run could result in a burning odor.The root cause of the unit not powering on was due to a blown fuse in the power inlet module.The power inlet module is the location of the ac power inlet, power switch, and fuses of the cart.One of the fuses blowing would prevent the cart from powering on as a precaution.Finally, the root cause of the iv pole being stuck was due to a combination of the control board and iv pole motor failing.The control board oversees the electrical capabilities of the cart; the board malfunctioning could deny the unit the ability to lower the iv pole properly in an electrical capacity.As mentioned before, the iv pole motor controls the speed at which the iv pole raises and lowers.The motor failing would compound the control board failure in a mechanical capacity by being unable to lower the iv pole.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the valve pack was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may require additional actions.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).

Event Description

It was reported that the unit had a burning odor.Additionally, the cart is not powering on the iv pole is fully extended.The event occurred during surgery.No adverse events were reported as a result of this malfunction.

• 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: 9097827
• MDR Text Key: 195580390
• Report Number: 0001954182-2019-00059
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2019

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: 00514010100
• Device Lot Number: 0028154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 09/23/2019; 10/16/2019
• Supplement Dates FDA Received: 09/26/2019; 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1