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

Model Number N/A

Device Problems Device Alarm System (1012); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).The k081047; k123188; k133786.The product will not be returned to zimmer biomet for investigation because it was evaluated by an external contractor.However, the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product evaluated by external contractor.

Event Description

It was reported that during surgery the unit was leaking and setting off the isolation alarm in that operating room.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4).The previous repair report for ultra duo flex cart unit serial number 54046, 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.Mera hmc was contacted about the cart and dispatched a service technician to be at the site.On 01 august 2017, the technician found that the unit was leaking in the valve pack.On 10 aug 2017, he replaced the valve pack twice, but the problem persistence; suspected bottom plate crack.So the exchange was initiated.An exchange for the new cart was scheduled.A new cart was shipped from riverside to the facility (shipping# (b)(4)).On 24 aug 2017, the new cart was confirmed to have been delivered to the facility and premier medical contracting llc was dispatched a service technician to the site to perform exchange.The technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended and placed the cart into service without further incident.The technician then repackaged the new cart so it can be returned.The exchanged cart was picked up from the facility the exchange cart was confirmed to have been returned to riverside on 01 sept 2017 as noted in zpm 13.0139 a returned equipment log.While the service technician confirmed the reported event and found that the unit was leaking from the valve pack, replacing the valve pack did not resolve the issue and the cart was exchanged.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.

• Brand Name: ULTRAFLEX DUO HIGH FLUID CART
• 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: 6825604
• MDR Text Key: 83850033
• Report Number: 0001954182-2017-00022
• 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: 10/12/2017

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: ULDU500R
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2015
• 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