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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number ULDU500
Device Problem Fluid Leak
Event Date 11/14/2018
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). The previous work order in customer relationship management (crm) 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 work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed. On 14 november 2018, it was reported from (b)(6) that a unit had a fluid leak. On 14 november 2018, (b)(4) 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 unit did have a fluid leak. The technician noted that caps were being used in place of manifolds which was causing the leaking. The technician used the instructed manifolds (per the ifu) and then verified that the unit was functioning as intended. The technician then returned the unit to service without further incident. The device was tested, inspected. Service work order (b)(4) on 14 november 2018. Based on the information provided, the root cause of the unit leaking was due to the account using a manifold lid and not using the entire manifold assembly when processing carts. The zimmer biomet transposal ultra evacuation technical manual states on page 9 to verify that all reservoirs have green lids/manifolds and that all of the ports are capped. 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 fluid leak. The event occurred during cleaning. No adverse events were reported as a result of this malfunction.

 
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Brand NameULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
Type of DeviceAPPARATUS, 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 Key8293866
Report Number0001954182-2019-00011
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/31/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULDU500
Device LOT Number0021659
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/31/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/18/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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