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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Pma/510k number: k081047; k123188; k133786.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 cart during surgery.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The device history record (dhr) for ultra duo flex fluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Using crm to query for serial number (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical.The reported event was not confirmed by the service technician who performed the repair per cl ¿ repair carts rev.3.On (b)(6) 2017, it was reported from (b)(6) hospital that a cart was leaking fluid from the bottom of the unit.On 29 august 2017, rep-lite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and was unable to confirm that the cart was leaking, but did find that the cart was giving drain errors and tandem errors.He replaced the level sensor in cylinder #2 with duo quad level sensor service kit (part # 91584, lot code 0025973) and the bumper mount with a car skirt mount kit (part # 76022, lot code 0022575) 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 as per cl ¿ repair carts rev.4.Service work order (b)(4) on 29 august 2017.The root cause for the unit leaking fluid could not be determined.The reported event was not confirmed during inspection of the device.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
• 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: 6872364
• MDR Text Key: 86719907
• Report Number: 0001954182-2017-00028
• 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: 11/01/2017

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: ULDU500
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/18/2017
• Supplement Dates Manufacturer Received: 11/01/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2014
• 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