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

Catalog Number 00514010100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

The event recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow-up mdr will be submitted.

Event Description

It was reported that the during a full soak the floats came off the level sensor and the cart was reading full on both cylinders even though it was empty.The event occurred during cleaning.No adverse events were reported as a result of this malfunction.

Event Description

No additional event information was received.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair record for intellicart system 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 record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.On 18 january 2019, it was reported from oregon surgical institute that during a full soak the floats came off the level sensor and the cart was reading full on both cylinders even though it was empty.On 18 january 2019, pacific rim mechanical was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that the level sensor floats had fallen off of the level sensors, and the unit was reading full when empty.The technician removed both manifold housings and placed the floats back on the level sensors and then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac.Service work order dms-49234-k9c2l9 on 18 january 2019.The root cause for the unit reading full when empty was due to the level sensor floats falling off of the level sensor.The level sensor floats ride along the level sensor to determine the fluid levels in the cylinder, and if the floats fall off of the level sensor it would cause the cart to misreport fluid levels.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the level sensor was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

• Brand Name: DUO FLUID CART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8271332
• MDR Text Key: 133937975
• Report Number: 0001954182-2019-00008
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 00514010100
• Device Lot Number: 0026600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1