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U.S. Department of Health and Human Services

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

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010200
Device Problem Fluid Leak
Event Date 08/22/2018
Event Type  Malfunction  
Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4)/. The device history record (dhr) review for intellicart fluid 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. Using crm to query for serial number (b)(4) the device was noted to have not been previously repaired by zimmer biomet surgical. On (b)(6) 2018, it was reported by saint vincent health system that the unit was leaking from the bottom during use. Md biomedics was contacted about the issue and service technician was dispatched to the site. On (b)(6) 2018, technician found that the unit had cracked bottom plate crack. So he decided to exchange the cart. An exchange for the new cart was scheduled. A new cart (sn# (b)(4)) was shipped from riverside to the facility (shipping#(b)(4)). On (b)(6) 2018, 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 30 aug 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 04 september 2018 and it was refurbished without any further evaluation. The cart was return to riverside for further evaluation. On (b)(6) 2018, the investigation was performed on the cart and found that the unit had crack at drain port in the bottom plate. It was also found that the cart had a vacuum pump was loud. Service work order dms-45957-w5k9s2 on 22 august 2018 notification of defect was created for the cylinder bottom plate fracturing along the knit line at the drain port of the bottom plate for intellicart. Supplier notice was implemented on 24 april 2017 as an outcome of this notification of defect and was to improve the injected molding process to better support the strength of the knit line. Since the notice was issued, however, it has been found that the cylinder bottom plate can still fracture along the knit line of the drain port. An issue evaluation and action procedure were issued to further address this bottom plate crack along the drain port on the intellicart. A supplier action was issued to the supplier for the loud noise issue due to rod alignment and supplier had implement deviation process to resolve the issue. However, with information, we were unable to determine whether this pump had bad rod alignment or not. Therefore, we were unable to determine whether this complaint related to the supplier action or not.

 
Event Description

It was reported that the duo fluid cart had fluid leak from the bottom during surgery. There was no medical intervention/additional surgical procedure required and another device was used to complete/finish the surgery. There was no harm and no delay reported.

 
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Brand NameDUO FLUID CART WITH SMOKE EVACUATOR
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 Key7874872
Report Number0001954182-2018-00060
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 09/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010200
Device LOT Number0023882
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/04/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/03/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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