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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2017, it was reported from (b)(6) hospital that fluid was leaking from the bottom of the cart.(b)(4) was contacted about the cart and dispatched a service technician to be at the site the following day.On 22 february 2017, the technician arrived at the site and confirmed that the cart was leaking fluid.He then discovered upon further inspection that there was a crack in the drain fitting below cylinder #1.An exchange was scheduled for the cart.On 22 february 2017, a new cart (serial # (b)(4)) was shipped from dornoch to the hospital.The cart was confirmed to have arrived at the site on 23 february 2017 and a service technician from (b)(4) was dispatched to the site to perform the exchange.On 24 february 2017, the technician arrived at the site and installed the new cart.The technician verified that the cart was functioning as intended and then placed the cart into service without further incident.The technician then repackaged the device, so that it could be returned to dornoch.The product was noted to have been 28 february 2017 and a returned product investigation was performed on the device on 1 march 2017.It was noted during the investigation that there was a crack at the drain hole on the bottom plate for cylinder #1 and that fluid was leaking out through the bottom of the cylinder plate.Intellicart system, serial number (b)(4), was manufactured on 28 december 2016 and was 2 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 not been previously repaired by zimmer biomet surgical.Review of all notifications of defect for the cylinder bottom plate revealed that there was one associated with the drain hole on the cylinder bottom plate having a crack through it ((b)(4)).The work order that the complaint is associated with is listed within the scope of the investigation, so the notification of defect is related to the reported event.No complaint history review from the etq reliance system can be performed since the intellicart is new product that had been only recently released to market.The root cause of the cart leaking from the bottom of the device could not be specifically determined, but was most likely due to a design flaw with a previous version of the cylinder bottom plate as noted in notification of defect (b)(4).The cylinder bottom plate found within the cart was noted to have been associated with an earlier revision of the component.The cylinder bottom plate was also noted to have been updated to add a flat area under the cylinder to prevent flexing and increase the long term reliability of the component as well as had the ribs attached to the drain port and spray head opening raised to increase support to the molding knit lines at the drain port and spray head openings.The lower ribs attached to the drain port and the unflatten surface on the previous version of the cylinder bottom plate would have not allowed the drain port to have the necessary support to withstand the applied force that the molding knit line on the drain port would be exposed to when the device would be operated.When the customer would then attempt to operate the device, the applied force on the drain port could then cause the mold to break down at an accelerated rate at the molding knit line and therefore cause the component to fracture along this line.The fracture drain port would then allow fluid to seep out from the drainage line and therefore out into the basin of the cart.The fluid could then leak out the bottom of the cart through the ventilation ports located in the bottom of the cart.If any information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the fluid was leaking from bottom of duo fluid cart.Additional information received from the customer on march 15, 2017 stated that the cart was leaking bodily fluid from the bottom of the cart to the floor.The leak was noticed throughout the day and there was no specific time noted.All personnel were wearing the proper ppe (personal protective equipment) and there was no patient or user harm or injury.The device was removed and alternate device was used.No adverse events have been reported as a result of the malfunction.

• 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
• 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: 6428374
• MDR Text Key: 70769993
• Report Number: 0001954182-2017-00003
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2017

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: 00514010100
• Device Lot Number: 0023580
• Other Device ID Number: SEE H-10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1