MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number ULDU500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The evaluation and investigation are in process.Once the investigation is complete, a supplemental medwatch will be filed.Product not returned; evaluated on site.

Event Description

Ultra duo high fluid cart was leaking when the unit had docked.Fluid was coming from around the blue caps and the bottom of the reservoir.The event occurred during cleaning.No adverse events were reported as a result of this malfunction.

Event Description

No additional information.

Manufacturer Narrative

This follow up report is being submitted to report 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.Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 2 times, the previous repair being for a receiver replacement on 3 july 2014.The receiver is not associated with the current repair.Thus, this repair was a non-related issue.Using view 09-23 from the etq reliance system, there were 304 complaints that contained part number: uldu500 lot# n/a and complaint description with the keyword: leaking.The highest occurrence for a given manufacture date was 19.The keyword of leaking fluid was chosen as a filter based upon the reported failure of it was reported that the unit was leaking when the unit had docked.Using view 09-23 from the etq reliance system, there were 38 complaints from 31 january 2018 to 20 march 2019 that contained part number: uldu500, complaint description with the keyword: leaking.The keyword of leaking was chosen as a filter based upon the reported failure of it was reported that the unit was leaking when the unit had docked.On 31 january 2019, it was reported from (b)(6) center that the unit was leaking when docked and cleaning.Fluid was coming out from around the blue caps, and the bottom of the reservoir.On 31 january 2019, a zimmer biomet authorized repair technician was contacted about the cart.Technician followed up with account to confirm if they wanted service for the issue.On 5 february 2019 the technician following up on the service request was able to determine that the account was using just the manifold caps during cleaning instead of the manifold assembly.Account confirmed that when a wash cycle was attempted with manifolds there was no further leakage.No repair checklist was required per crm.Service work order (b)(4) on 31 january 2019.This complaint cannot be confirmed, as a technician was not dispatched to the site to inspect the device.Additionally, for this reason a root cause cannot be selected for the reported event.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8310832
• MDR Text Key: 135180288
• Report Number: 0001954182-2019-00014
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K123188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1