MAUDE Adverse Event Report: DORNOCH DUO FLEX FLUID CART

Model Number N/A

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

The device 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 during surgery the duo flex fluid cart tubing sprayed onto the sterile field.

Manufacturer Narrative

The ultra duo high fluid cart, ul-du100, serial number (b)(4), was manufactured on 8/1/2013 and is not an out of box failure.The unit had been serviced once prior to this complaint; the work order took place on 4/27/2015 and resulted in the replacement of the cl housing on the unit.No relevant manufacturing factors found during complaint investigation.No systemic issues were identified.On (b)(4) 2015, the duo cart was evaluated and it was noted that one of the suction tubes sprayed onto the sterile field.It was not reported if either the patient or staff was injured.No other damage, modifications or issues were reported.A repair technician from (b)(4) services found the unit to be functioning as intended.After talking to the hospital staff, he discovered the surgical tubing was not fully seated on the manifold port due to the user pulling on the tube during use.The improper seating compromised the vacuum in the tubing which resulted in the reported backflow of fluid onto the sterile surface.The technician also confirmed that there was no contamination to the patient or the or staff, and no harm had occurred to any personnel or patients.The reported event was confirmed by the repair technician; no repair took place, no parts were returned to (b)(4) for evaluation.The cause of the reported event was that the suction tubing was not fully seated to the manifold port during use.As noted by the repair technician, the most likely root cause was the user pulling on the suction tubing with too much force during the handling of the unit which caused the vacuum within the tubing to be compromised.Events of this nature will be tracked to determine what, if any, additional actions are necessary.The work order was closed as the repair technician found the device to be functioning as intended and the unit is available for continued use by the customer.

• Brand Name: DUO FLEX FLUID CART
• Type of Device: DUO FLEX FLUID CART
• 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: 5178188
• MDR Text Key: 29951907
• Report Number: 0001954182-2015-00004
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• 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-DU500
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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