MAUDE Adverse Event Report: DORNOCH REFURB DUO FLEX CART; REFURB ULTRAFLEX¿ DUO #UL-DU500

Model Number N/A

Device Problems False Reading From Device Non-Compliance (1228); Occlusion Within Device (1423); Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

The product will not be returning to the manufacturer for evaluation; however the investigation was not completed at the time of this report.A follow up medwatch will be submitted once the investigation is complete.

Event Description

It was reported that the cart # 54131 overflowed during a surgical case.It was noted that the cart was clean on the outside this morning and the cart was processed.Additional information received on jun 16, 2016 stated that the reported issue was noticed during surgery and there was no patient involvement.It was confirmed that there was a fluid overflow; however no backflow into the patient and no harm to the patient or staff or impact to the procedure as a result of the reported issue.He explained that the unit was not reading the correct level due to a blood clot holding down the level sensor and the hospital staff were wearing ppe.

Manufacturer Narrative

(b)(4) was contacted about the cart and dispatched a service technician to be at the site the following day.On june 10, 2016, the technician arrived at the site and confirmed that the cart had overflowed with fluid.He then discovered upon further inspection that there was a large biomass inside of a cylinder.The technician removed the biomass and then verified that the cart was functioning as intended.The cart was then returned to service without further incident.

Manufacturer Narrative

Ultra duo flex fluid cart, serial number (b)(4), was manufactured on october 6, 2014 and was 20 months old at the time this complaint was generated.The device history record (dhr) review 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 been previously repaired by zimmer biomet surgical once for a non-responsive monitor on (b)(6) 2016.The monitor was not associated with the reported event, so this was most likely a non-related issue.The reported event was confirmed by the service technician that performed the repair.On (b)(6) 2016, it was reported from (b)(6) that a cart overflowed during a case.On (b)(6) 2016, additional clarification from the customer revealed that the reported event occurred during surgery and that there was no patient involvement.There was no harm to the patient or operator associated with the reported event, no surgical procedure was affected, and the hospital staff was noted to be wearing personal protective equipment (ppe) at the time of the reported event.The customer also stated that the cart was not reading the correct fluid level due to a bolt clot holding down the level sensor.(b)(4) was contacted about the cart and dispatched a service technician to be at the site the following day.On april 10, 2016, the technician arrived at the site and confirmed that the cart had overflowed with fluid.He then discovered upon further inspection that there was a large biomass inside of a cylinder.The technician removed the biomass and then verified that the cart was functioning as intended.The cart was then returned to service without further incident.No repair checklist was required per customer relationship management (crm).Service work order (b)(4) on june 9, 2016.The root cause of the cart overflowing during a case was due to a large biomass coagulating inside of the cart.The instructions for use state after the cart is used, the cart needs to be transported to the evac so that it can be emptied and cleaned.If the customer would have foregone processing the cart and allowed fluid to sit inside of the cylinders, the biomaterial inside of the cylinders could begin to coagulate and congeal.The biomaterial could then prevent the fluid from emptying from the cylinder as well as prevent the level sensor float from measuring the fluid level inside of the cart.If biomaterial would have held the level sensor float down, when the customer would then attempt to operate the cart, the cart would not be able to properly shut off the cart when it would reach the 16.5 liter limit.The customer could then allow the cylinders to then overfill with fluid and therefore either spill out from the manifold housing or leak out of the cylinder through the vent line.The leaking fluid would then prevent the cart from operating as intended.Recommended actions: no recommended actions at this time.

• Brand Name: REFURB DUO FLEX CART
• Type of Device: REFURB ULTRAFLEX¿ DUO #UL-DU500
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer (Section G): DORNOCH; 200 northwest parkway; riverside MO 64150
• Manufacturer Contact: david bailey ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 5751882
• MDR Text Key: 49029837
• Report Number: 0001954182-2016-00001
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: No
• 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