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

Catalog Number ULDU500SE

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

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The investigation is still in progress.Once the investigation is complete a follow up mdr will be submitted.

Event Description

It was reported that the unit was not registering fluid levels correctly and when it was draining it was leaking from the bottom.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 report for ultra duo flex fluid cart serial number 160169 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.On 12 december 2018, it was reported from (b)(6) hospital that the unit was not registering fluid levels correctly and when it was draining it was leaking from the bottom.On 12 december 2018, replite 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 unit was not registering fluids appropriately, and that the unit had leaked out of the bottom.Technician found that there was a suture wrapped around the level sensor float and level sensor prohibiting the movement of the float.Technician removed the foreign object then verified that the unit was functioning as intended, and returned the unit to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 12 december 2018.The service technician was able to confirm the reported event of the fluid level not reading correctly.The root cause of the event was due to a foreign material attached to the level sensor, which prevented it from accurately reading fluid levels.When foreign materials other than fluid enters the cylinder they can become attached to or cause the level sensor, and level sensor float to have inaccurate readings.The device was noted to be functioning as intended after a foreign object was dislodged from the level sensor.Additionally, the transposal ultra cart instructions for use (gd-99022, rev.9) provides at page 3 not to use the device outside the defined indications of use, that the reservoirs are for fluid collection only, and that material should not be placed inside of the cart for disposal.The reported event of the unit leaking from the bottom cart was confirmed, and the root cause for this event is also due to the materials attached to the level sensor.If the level sensor is unable to read fluid levels correctly the cylinder can become too full, and fluid can leak from the unit.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 WITH SMOKE EVACUATOR
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8228368
• MDR Text Key: 132572149
• Report Number: 0001954182-2019-00003
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K133786
• 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: 02/07/2019

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: ULDU500SE
• Device Lot Number: 0022220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1