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 Consequences Or Impact To Patient (2199)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Pma/510k: k081047; k123188; k133786.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 1 time, the previous repair being for drain error on cylinder #1 on (b)(6) 2016.The valve pack issue was not associated with the current repair service, so the previous repair was a non-related issue.On (b)(6) 2018, it was reported from (b)(6) hospital that the unit was leaking fluid during a case.Replete was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site on (b)(6) 2018 and confirmed that the cart was leaking as he found that the lower sound material was wet.The technician pulled the material out and completely dried the inside of the unit, ran multiple wash cycles and could not find any leak and then replaced the duo lower sound material (part # 70011 and lot code # 0025579) and 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)(6) 2018.While the service technician confirmed the reported event and the device was noted to be functioning as intended after the lower sound insulation material was replaced, it is unknown with the information provided from where the unit was leaking as the technician could not find any leak during troubleshoot.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.

Event Description

It was reported that the unit was leaking fluid during surgery.No harm and no delay.

• 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: 7746814
• MDR Text Key: 115926172
• Report Number: 0001954182-2018-00043
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/20/2018

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: 06/22/2018
• Initial Date FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/21/2015
• 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