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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The product will not be returned zimmer biomet for investigation.Once the investigation has been completed, a follow up mdr will be submitted.Pma/510k: k081047; k123188; k133786.Evaluated by external contractor.

Event Description

It was reported that the unit was leaking from the bottom.The event timing was unknown.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The previous repair report for ultra duo flex fluid cart, 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 repair report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.On (b)(6) 2017, it was reported from (b)(6) that this unit was leaking from the bottom.Sales representative was contacted about the cart as the account suspected that the unit has a cracked bottom plate as this unit has had the valve pack replaced three times.Due to the history with leaks/valve pack replacements the sales rep, service manager and all decided to exchange the unit.Exchange paperwork was created and submitted.No repair checklist was required as per crm.An exchange for the new cart was scheduled.A new cart was shipped from (b)(4) to the hospital.On (b)(6) 2017, the new cart was confirmed to have been delivered to the hospital and replite was dispatched a service technician to the site to perform exchange.On (b)(6) 2017, the technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended and placed the cart into service without further incident.The device was tested and inspected without any installation checklist as per crm.The technician then repackaged the new cart so that it returned to service without further incident.The exchanged cart was picked up from the hospital (confirmation number: (b)(4)).The exchange cart was confirmed to have been returned to (b)(4) on 7 nov 2017 and the unit was scrapped without any further evaluation as per returned equipment log details.Service work order (b)(4) on (b)(6) 2017.The service technician never visited initially to inspect the reported event as the unit was scheduled for exchange based on the previous repair history of the unit; it is unknown with the information provided how the unit was damaged which caused unit to leak.Therefore, based on the information provided, a specific root cause of the reported event cannot be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE
• 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: 7006067
• MDR Text Key: 92467388
• Report Number: 0001526350-2017-00823
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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: ULDU500R
• Device Lot Number: N/A
• Other Device ID Number: (01) 00889024465824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1