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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is still in progress.Once the investigation is complete, a follow up mdr will be submitted.

Event Description

It was reported that the unit was down due to surgery.No harm or injury to the patient was reported.Attempts have been made and no further information is available at this time.

Event Description

It was reported that the unit was down during surgery and leaking no harm or injury to the patient was reported.Attempts have been made and no further information is available at this time.

Manufacturer Narrative

This follow up report is being submitted to report additional information the previous work order in customer relationship management (crm) for intellicart system serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired once, the previous repair being for an issue with the receiver on 16 january 2018.The receiver is not associated with the current repair.Thus, this repair was a non-related issue.Using view 09-23 from the etq reliance system, there were 02 complaints that contained part number: 00514010200 lot# 0025197 and complaint description with the keyword: ¿down.¿ the highest occurrence for a given manufacture date was 04.The keyword of ¿down¿ was chosen as a filter based upon the reported failure of ¿unit was down.¿ using view 09-23 from the etq reliance system, there were 29 complaints from 11 may 2017 to 30 may 2018 that contained part number: 00514010200, complaint description with the keyword: ¿down.¿ the keyword of ¿down¿ was chosen as a filter based upon the reported failure of ¿unit was down.¿ on (b)(6) 2018, it was reported from university medical center at (b)(6) that a unit was down.On (b)(6) 2018, replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and evaluated the device and found a note stating that the unit had over filled during a hybrid case.He found that both cylinders were full and fluid had over filled to the point that all sides of the unit were wet, the front window tint was no longer functional, the sound material was saturated, and the vacuum system had signs of fluid having been pulled in.The technician then scheduled an exchange.A new cart was shipped from riverside, and the replacement cart was noted to be delivered on 16 may 2018.Replite dispatched a service technician to the site to perform the exchange.On 16 may 2018 the service technician confirmed that the exchange was completed and that the exchanged unit was packaged and ready for return.The cart was refurbished.Service work order (b)(4) on 11 may 2018.Although the reported event was confirmed during inspection of the device it cannot be specifically determined from the information what caused the unit to be down.Therefore, the root cause could not 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 WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 7538904
• MDR Text Key: 109110504
• Report Number: 0001954182-2018-00030
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: PK162421
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1