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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).K081047; k123188; k133786.Product evaluated by external contractor.Once the investigation has been completed, a follow-up mdr will be submitted. .

Event Description

It was reported that the unit was leaking fluid from bottom of quad cart.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

The previous repair record for ultra evacuation unit was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.The device was noted to have been previously repaired nine times, the previous repair being for an issue with the pickup straw on 31 august 2017.The pickup straw is not associated with the current repair.Thus, this repair was a non-related issue.Replite was contacted about the cart and dispatched a service technician to be at the site.On 08 december 2017, the technician found that the leak was coming from the evac, and noted a punctured peristaltic pump hose.He replaced the peristaltic pump hose and then verified that the device was functioning as intended.The cart was then returned to service without incident.The unit was tested, inspected, and repaired.The root cause of the reported leaking was due to the punctured peristaltic pump hose on the evacuation unit.The service technician confirmed the reported event when he found the punctured peristaltic hose and noted that the device was functioning as intended after replacing the hose.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
• 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: 7165728
• MDR Text Key: 96495474
• Report Number: 0001954182-2018-00001
• 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
• Report Date: 01/24/2018

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 Model Number: N/A
• Device Catalogue Number: ULDU500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2012
• 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