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 Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

Ultra duo high fluid cart was leaking from the manifold housing on cylinder 1.The event occurred during cleaning.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

On 15 january 2019, it was reported from decatur memorial hospital that a duo unit was leaking from the manifold housing on cylinder 1.On 15 january 2019, burdick plumbing & heating co, inc was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that there was leakage from the manifold housing on both cylinders.The technician replaced the cl500 manifold housings (part #91927 and lot code #0025590) 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 dms-49150-v4n4s2 on 15 january 2019.Although the reported event of leaking manifold housings was confirmed during the inspection of the device, based on the information available it is unknown what caused the manifold housings to leak.Therefore, based on the provided information, the specific root cause cannot be determined.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the manifold housings of the unit were replaced.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 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: 8267131
• MDR Text Key: 133744180
• Report Number: 0001954182-2019-00007
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• 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: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1