MAUDE Adverse Event Report: DORNOCH DUO FLEX FLUID CART SMOKE

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was initially reported that during cleaning, the ul-du500se was leaking from bottom.It was later noted that the unit was leaking out the cylinders and has blood down the front.Follow up with (b)(6) hospital did not identify that there was patient/user harm or injury; nor adverse event to the patient/operator in this specific occurrence.

Manufacturer Narrative

Ultra duo flex fluid cart, serial number (b)(4), was manufactured on 3/13/2014 and was 19 months old at the time this complaint was generated.The unit has not been repaired previously, as noted in customer relationship management system (crm).The device history record (dhr) review noted no related non-conformances, request for deviations, change notices or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.For the current event, no related manufacturing factors were found during the complaint investigation.The customer provided details that the unit is leaking out the cylinders and has blood all down the front of the cart.A service technician from m&m services visited the customer to review the reported issue.There is no investigation or repair notes in crm or contained within the checklist.Also, there is no return product investigation report (rpir).It was decided that the ultra duo flex cart ul-du500, serial number (b)(4), will be exchanged with ultra duo flex high fluid cart refurb ul-du500r, serial number (b)(4).Service work order (b)(4) dated 10/5/2015.The customer¿s reported event was not reproduced by the service technician nor by dornoch.The cause of the reported event could not be specifically determined as there is no investigation repair notes in crm or contained within the checklist.Also, there is no rpir.Events of this nature could likely be related to an issue with the level sensor not correctly reading and registering fluid levels in the cylinder.Also, there could have been a clog in the drain system that may be a result of disposal of improper material in the cart, clotting of blood during processing, or a large amount of rich blood collected during a procedure.Recommended actions from "dornoch transposal ultra cart instructions for use manual" gd-99022 rev.H: do not use this system outside the scope of the defined indications for use.Reservoirs are for surgical and bodily fluid collection only; do not place any items into the reservoir for disposal.

• Brand Name: DUO FLEX FLUID CART SMOKE
• Type of Device: DUO FLEX FLUID CART SMOKE
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: jennifer hutchison ; 200 northwest parkway; riverside, MO 64150 ; 8165052226
• MDR Report Key: 5180952
• MDR Text Key: 30065559
• Report Number: 0001954182-2015-00005
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• 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: UL-DU500SE
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2014
• 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