MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART CONTAINS: SMOKE EVAC

Model Number N/A

Device Problems Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591)

Patient Problem Exposure to Body Fluids (1745)

Event Date 10/12/2015

Event Type  Injury  

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 reported that after the completion of surgery, there was a tandem error on the ultra duo high fluid cart but it could not be confirmed of which cylinder.During maintenance of the device, the hospital employee was exposed while in the manual mode; the cylinder was overflowed and the contents got in his mouth.During follow up with the employee, the employee stated that he was wearing ppe (safety glasses, suit, gloves, booties, headcover) with the exception of a mask or shield.

Manufacturer Narrative

Ultra duo flex high fluid cart w/smoke evac ul-du500, serial number (b)(4), including smoke evac and iv pole brackets was manufactured on october 31, 2013 and was 24 months old at the time this complaint was generated.The cl-4.30 software upgrade was completed on (b)(6) 2015.A review of the device history record (dhr) observed no standard rework, deviations, and concerns.The unit has been repaired three times previously, with the most recent repair on (b)(6) 2015 as noted in customer relationship management (crm).No relevant manufacturing factors found during complaint investigation.No systemic issues were identified.During the conversation with the customer, it was mentioned that he was exposed while in the manual mode he overflowed the cylinder and the contents got in his mouth.A stated in clinical follow-up conducted (b)(6) 2015, information received indicated the hospital personnel was wearing personal protective equipment (safety glasses, suit, gloves, booties, head cover) with the exception of a mask or shield.The event occurred after the completion of a surgery.A service technician from m&m services verified the tandem error on ultra suction cart cylinder #2 and replaced the defective level sensor at cylinder #2 position using part number 91584 level sensor service kit, lot code 0020612.The service technician checked the level sensor by raising the float doughnut manually, then checked the cart for any water leaks, and again looking for correct suction in the or mode.The ultra suction cart is working at 100% now.The unit was repaired, inspected, and tested per repair instructions and documented on repair checklist.(b)(4), dated october 12, 2015.The root cause of the reported event could not be specifically determined, but could most likely be related to moisture entering at the base of the sleeve which could cause a premature failure of the level sensor.The fluid waste management system is intended for collection of surgical and bodily fluids, only.Ultra duo flex high fluid cart w/smoke evac ul-du500, serial number (b)(4), including smoke evac and iv pole brackets was repaired, inspected, and tested per repair instructions and documented on repair checklist.The repair checklist is attached to the complaint file.Recommended actions: 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: ULTRA DUO HIGH FLUID CART CONTAINS: SMOKE EVAC
• Type of Device: ULTRA DUO HIGH FLUID CART CONTAINS: SMOKE EVAC
• 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: 5191421
• MDR Text Key: 29946008
• Report Number: 0001954182-2015-00006
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• 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: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULDU500SE
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other