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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 Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Date 08/16/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Udi: (b)(4).On (b)(6) 2019, it was reported from (b)(6) medical center that an intellicart unit was not reaching the set vacuum point and that there was also a concern for a burning smell.The previous work order in customer relationship management (crm) for intellicart system 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.No additional action needed rationale: based on the complaint history review, there is no need for additional action, as the vacuum issue experienced in this event was addressed in a scar.Replacement of failed ge filters that are subject of the scar is ongoing.On (b)(6) 2019, it was reported from (b)(6) medical center that an intellicart unit was not reaching the set vacuum point and that there was also a concern for a burning smell.On 16 august 2019, replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed the vacuum issue; he found that the ge carbon filter on the unit had failed.He was unable to replicate a burning smell on this cart, and believed it was from another piece of equipment in the room the cart was in.The technician replaced the ge carbon filter with a new buffalo filter (part #30041) 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, and repaired.Service work order (b)(4) on 16 august 2019.The root cause for the unit not reaching the set vacuum point and experiencing suction issues was due to a failed ge carbon filter.A scar is associated with the carbon filters showing repetitive issues with retention of the carbon particles.These particles can clog the vacuum pump which in turn disrupt the air flow through the vacuum pump, preventing the component from creating the pressure gradient needed to generate suction.Because the unit¿s failed ge filter was replaced with a buffalo filter, a scar is related to the reported event.In addition, the reported event of the burning smell concern was not confirmed during inspection of the device as the technician was unable to duplicate it and did not find the failed carbon filter as the source of the smell.Therefore, based on the information available, a specific root cause of the burning smell cannot be determined.The device was noted to be functioning as intended after the carbon filter was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time, as a scar has already been implemented for failed ge filters and replacement of the failed filters is ongoing at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may require additional actions.
 
Event Description
It was reported that prior to surgery, the cart vacuum was not reaching the set point and it had a concern of a burning smell.The event occurred prior to surgery.No adverse events were reported as a result of this malfunction.
 
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Brand Name
DUO FLUID CART
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 Key8945167
MDR Text Key207033376
Report Number0001954182-2019-00054
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00514010100
Device Lot Number0026018
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/16/2019
Initial Date FDA Received08/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2017
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
Patient Sequence Number1
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