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

Catalog Number ULDU500SER

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This mdr is being submitted as an initial/ final report.The device history record (dhr) for ultra duo flex fluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical.On (b)(6) 2018, it was reported from (b)(6) that a unit had cylinder #1 multiple tandem errors and cylinder #2 was not reading fluid volume from cases.Replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that the a/d values on both cylinders were not reading properly.He replaced the level sensors (part # 91584, lot code 0027604) (part # 91584, lot code 0028004) in each cylinder and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 25 july 2018.The root cause for the unit issuing tandem errors on cylinder #1 and not reading fluid volume on cylinder #2 was due to a malfunctioning level sensor in each cylinder.The level sensor is responsible for measuring the fluid levels in the cylinder, and a malfunctioning level sensor could issue tandem errors or not allow the unit to measure fluid volumes.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the level sensor in each cylinder was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Device evaluated by external contractor.

Event Description

It was reported that unit had cylinder 1 multiple tandem errors and cylinder 2 was not reading fluid volume from cases.The event timing was after surgery.No adverse events were reported as a part of this event.Device evaluation found that level sensors in both cylinders of the unit were showing incorrect readings.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR - REFURBISHED
• 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: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7765368
• MDR Text Key: 116875452
• Report Number: 0001526350-2018-00764
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK081047
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500SER
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2013
• 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