MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH POWER IV, REFURBISHED; SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT

Model Number N/A

Device Problem Incorrect Measurement (1383)

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

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.

Event Description

It was reported that outside of surgery, the cart was full but reads empty.Both cylinders/sides had incorrect information for the fluid volume.There was no patient involvement.Due diligence is complete and there is no additional information available.No adverse event is associated with this malfunction.

Manufacturer Narrative

This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the levels were not reading correctly.The level sensor bulb and riser were cleaned off and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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

There is no additional information available regarding the event.

• Brand Name: DUO FLUID CART WITH POWER IV, REFURBISHED
• Type of Device: SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16994549
• MDR Text Key: 315868298
• Report Number: 0001954182-2023-00063
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00889024501645
• UDI-Public: (01)00889024501645
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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 Model Number: N/A
• Device Catalogue Number: UE514010300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2020
• 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