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

Catalog Number ULDU500

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product will not be returned to zimmer biomet.Product is being evaluated by external contractor.Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that the unit was not reading the fluid level in either cylinder correctly.The event occurred during cleaning.There was no patient involvement.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).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 18 june 2019, it was reported from (b)(6) hospital that a duo cart unit was not reading the fluid level in either cylinder correctly.On 18 june 2019, replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed drain errors on cylinder 1 and 2 after checking the error log.He found a hydrophobic filter inside cylinder 1 which was causing the volume reading issues.He also used the clot buster to clear both cylinders to clean any bioburdens, and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 18 june 2019.The root cause for the unit not reading fluid levels correctly was due to the presence of a hydrophobic(manifold) filter in cylinder 1 and bioburden in both cylinders.The manifold filter can fall out of the manifold after hardening post-use, and this would cause the unit to be unable to read fluid levels correctly and issue the discovered drain error.In addition, the presence of bioburden in the cylinders could obstruct the drain and valve pack, again making the unit issue drain errors and affecting its ability to read fluid levels.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the hydrophobic filter was removed and bioburden cleared with clot buster.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information.

• Brand Name: ULTRA DUO HIGH FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8712703
• MDR Text Key: 148446950
• Report Number: 0001954182-2019-00040
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K133786
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500
• Device Lot Number: 0020922
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1