MAUDE Adverse Event Report: DORNOCH ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED; APPARATUS, SUCTION, WARD USE

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The k081047; k123188; k133786.The previous repair report for ultra duo flex fluid cart 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 repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.On (b)(6) 2018, it was reported from (b)(6) center that the unit was leaking.(b)(6) was contacted about the unit and dispatched the service technician to be at the site.On (b)(4) 2018, the technician replaced valve pack to resolve the issue.Then he found lower sound material was saturated and fan was shorted out.He replaced the sound material and fan.He then examined the unit and found that the vacuum pump was tripping gfi breaker.Since considering the volume of the workload in this unit, the unit was decided to exchange and process was initiated.An exchange for the new cart was scheduled.A new cart was shipped from (b)(4) to the facility.The new cart was confirmed to have been delivered to the facility and service company was dispatched a service technician to the site to perform exchange.On (b)(4) 2018, the technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended and placed the cart into service without further incident.The technician then repackaged the old cart so that it returned to service center.The exchanged cart was picked up from the facility.The exchange cart was confirmed to have been returned on 22 march 2018 and it was scrapped without any further evaluation as noted in a return equipment log.Service work order (b)(4) on 12 march 2018.Based on the information, the root cause of the reported issue was due to the valve pack malfunctioning.The reported event was confirmed during inspection of the device.The valve can leak fluid if the valve pack is not seated properly with the bottom plate or if there is improper sealing with the o-ring.When the fluid was leaked from the valve pack, it can damage sound material, fan, vacuum pump and other electrical component which located at the bottom part of the unit.Since several components were damaged due to the leak, it was exchanged.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Device evaluated by contractor.

Event Description

It was reported that the unit was found to be leaking during a case.The event occurred during surgery.Follow up indicated that the valve pack was leaking fluid during surgery.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7381154
• MDR Text Key: 104040728
• Report Number: 0001954182-2018-00022
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• 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: ULDU500R
• Device Lot Number: N/A
• Other Device ID Number: (01)00889024465824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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