MAUDE Adverse Event Report: DORNOCH DUO FLUID CART - REFURBISHED; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number UE514010100

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: the unit was evaluated by an external contractor.Conclusion: the vacuum pump tube was touching the brass elbow of the vacuum pump; this caused the tube to heat up and smoke.The device history record (dhr) review for intellicart system serial number (b)(4), noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.On (b)(6) 2018, it was reported by (b)(6) hospital that the unit had a vacuum that was smoking.Replite was contacted about the issue and service technician was dispatched to the site.On (b)(4) 2018, technician found that the vacuum tube was touching the brass elbow of the vacuum pump.So he tied the vacuum tubing away from the brass elbow of the pump with the help of a zip-tie and verified that the unit was functioning as intended and return the unit back to service.The device was tested, inspected, and repaired.Based on the information, the root cause of the reported issue was due to vacuum pump tube was touching the brass elbow of the vacuum pump; which tends to heat up.Since the tube was touching the hot elbow, it would cause the tube to singe and generate a smoke smell.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the vacuum pump hose was tied away from vacuum pump brass elbow using a zip-tie.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that the unit had a vacuum that was smoking.The account alleged that the cart was emitting a smoke like smell.The event timing was prior to surgery.No adverse events were reported as a result of this malfunction.

• Brand Name: DUO FLUID CART - REFURBISHED
• 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: 7966428
• MDR Text Key: 124979469
• Report Number: 0001954182-2018-00066
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UE514010100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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