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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).A follow up medwatch will be submitted once the investigation is complete and a root cause has been established.

Event Description

It was reported that the duo fluid cart unit was leaking.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.It was reported from (b)(6) hospital that the unit # 1170764 had leaked in the operating room.Account processed the unit and after processing there was a 6 inch puddle under the cart.Replite was contacted about the cart and dispatched a service technician to be at the site.On feb 6, 2018, the technician confirmed leakage present in the bottom cabinet.Leakage appeared to be coming from around the plastic elbow located under cylinder 2.Exchange paperwork was created and submitted.No repair checklist was required as per crm.An exchange for the new cart was scheduled.A new cart was shipped from riverside to the hospital.On feb 8, 2018, the new cart was confirmed to have been delivered to the hospital and replite was dispatched a service technician to the site to perform exchange.On feb 8, 2018, the technician arrived at the site and installed the new cart.He then verified that the cart was functioning as intended and placed the cart into service without further incident.The device was tested and inspected without any installation checklist.The technician then repackaged the new cart so that it returned to service without further incident.The exchanged cart was picked up from the hospital the exchange cart was confirmed to have been returned to riverside on feb 19, 2018 and the unit was refurbished as per the details from zpm13.0139 returned equipment log.On feb 15, 2018, a returned product investigation was performed on the intellicart.The investigation revealed that there was a crack in the drain hole of the cylinder bottom (30044).Service work order (b)(4) on feb 6, 2018 the root cause of the reported event of unit leaking was due to crack in the bottom plate.The returned product investigation performed on the cart revealed that there was a crack in the bottom plate of cylinder #2.The reported event was confirmed during inspection of the device and the issue was resolved with an exchange.Nd riv-2017-0005 is associated with the bottom plate cracking along the drain port, but it is unknown how the crack occurred on the cylinder bottom plate, so it cannot be determined if this is related to the event.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
• 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: 7269838
• MDR Text Key: 100249336
• Report Number: 0001954182-2018-00012
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• 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: 26063
• Other Device ID Number: (01)00889024465992 (21)1170764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2017
• 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