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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).Pma 510(k): k081047; k123188; k133786.The product will be evaluated by an external contractor.Once the evaluation/investigation has been completed, a follow up mdr will be submitted.Product evaluated by external contractor.

Event Description

It was reported that the unit was leaking from bottom of the cart.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

This complaint is recorded with zimmer biomet under (b)(4).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.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired three times, the previous repair being for an issue with a valve pack on 16 november 2017.The valve pack is not associated with the current repair.Thus, this repair was a non-related issue.On (b)(6) 2017, it was reported from university of (b)(6) that a unit was leaking from bottom of cart.Day mechanical systems, inc was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that the level sensor was leaking.He replaced the level sensor (part # 91584) and the sound insulation (part # 70011) and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac rev.0.The root cause for the unit leaking from bottom of the cart was due to a loose level sensor.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the level sensor was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: ULTRAFLEX DUO HIGH 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
• 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: 7141877
• MDR Text Key: 95954388
• Report Number: 0001954182-2017-00045
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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: ULDU500SE
• Device Lot Number: 0019210
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1