MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number N/A

Device Problems Device Alarm System (1012); Overheating of Device (1437); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/20/2023

Event Type  malfunction  

Event Description

It was reported outside of surgery the unit had high temp alerts, and was smoking.There was no reported patient harm, or delay.Due diligence is in progress, no further information is available at this time.

Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.Customer has indicated that the product is in process of being reviewed by zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Dhr review: n/a.The unit was confirmed to be giving high temp alarms.The vent hose on the vacuum pump was found to be kinked and insulation was blocking the fan.The hose and insulation were reset.The unit was tested to verify proper operation and returned to service.Root cause: the vacuum pump is required to create suction in order for the unit to function as intended.Mechanical failure can occur within the vacuum pump assembly with either the pump failing to generate negative pressure, or with a failure of the carbon filter.Over time and with continuous use, the internal integrity of the vacuum pump can degrade and no longer be able to create the pressure needed for desired suction levels.Likewise, the carbon filter can back out of the assembly or over tighten, again causing suction failure.A mechanical failure of the component will cause an overall suction failure in the unit and will prompt vacuum sensor errors.Electrical failure can occur when the unit draws an excess of electrical current; this will cause the fuse for the vacuum pump to trip, denying the pump power and causing the component to fail and prompt vacuum sensor errors.Due to a range of external (non-design / non-manufacturing related) variables potentially impacting the component, identifying definitive causes for each vacuum pump failure is generally not possible.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time.Vacuum pump failures are a well-known failure mode, with no allegations of harm or injury to a patient.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may warrant further action.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information is available.

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17343777
• MDR Text Key: 319273518
• Report Number: 0001526350-2023-00758
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024501638
• UDI-Public: (01)00889024501638(11)230418
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00514010400
• Device Lot Number: 47388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• 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
• Patient Sex: Prefer Not To Disclose