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

Catalog Number ULDU500R

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device within the complaint was noted to have been conforming as intended during inspection of the device.As there is no non-conformances with the device, no device history records review, previous repair review, or complaint history review is required to be performed and no previous repair record is required to be attached to the complaint.On (b)(6) 2018, it was reported from (b)(6) hospital that the unit was leaking fluid during a case.Replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site on (b)(4) 2018 and opened back of the cart and found no liquids or could not find any sort of leaking fluid.The technician 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 (b)(4) 2018.The service technician could not reproduce the reported event.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.Device evaluated by external contractor.

Event Description

It was reported that unit was leaking fluid during a case.The event occurred during surgery.No harm and no delay was reported.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7753026
• MDR Text Key: 116122966
• Report Number: 0001954182-2018-00047
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU500R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2015
• 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