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

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.

• 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 Key: 8945167
• MDR Text Key: 207033376
• Report Number: 0001954182-2019-00054
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• 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 Number: 00514010100
• Device Lot Number: 0026018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1