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U.S. Department of Health and Human Services

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

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DORNOCH DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010100
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 05/07/2020
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). Udi: (b)(4). Investigation completed. This is an initial final report submission. Product evaluation: product review of the duo fluid cart serial number (b)(4) by zimmer biomet certified service repair technician on may 08, 2020 revealed that the iv pole limit switch wire had twisted around the iv pole and pulled out of the plug on the iv pole side. Iv pole wires came out of the connector. Product repair: repair of the device was performed by zimmer biomet certified service repair technician on may 13, 2020 which included replacement of the following: item# 00514012000, lot# 0042537, power iv pole. Review of the device history record(s) identified no deviations or anomalies during manufacturing. Device is used for treatment. Reported event is not related to a combination of products; therefore, a compatibility review is not applicable. A definitive root cause cannot be determined. The event is confirmed. Evaluated by external contractor.

 
Event Description

It was reported that the iv pole on this unit was stuck in the up position and then they tried to lower it rather than going down it would spin. The iv pole had also been raised so high that it was not able to be removed from the or and the room had to be closed. The event timing was after the case/ post surgery. There was no harm to the patient. Product evaluation investigation found indicated exposed wiring as the wires were exposed. No adverse events were reported as a result of this malfunction.

 
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Brand NameDUO FLUID CART
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 Key10120511
MDR Text Key200012591
Report Number0001954182-2020-00023
Device Sequence Number1
Product Code JCX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 06/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010100
Device LOT Number0027539
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 Received06/04/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/28/2018
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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