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 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the unit was leaking during procedure.The event occurred during surgery.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.The following sections were updated/corrected.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).In customer relationship management (crm), the previous work order for the device ((b)(4)) for intellicart unit, serial number (b)(4), was reviewed and noted no related non-conformance's, requests for deviation (rfd) or any other issues with the repair.The previous work order noted no issues with the device after repair 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 once; the previous repair being for account has a cart that is leaking on 9 oct 2017.This repair was similar in nature to the current repair.Service work order (b)(4) on 6 nov 2017.The reported event was confirmed by the service technician who performed the repair without any repair checklist as per crm.On 6 nov 2017, it was reported from great lakes bay surgery ct that the unit is leaking during procedure.Frontline medical equipment services was contacted about the cart and dispatched a service technician to be at the site.On 6 nov 2017, the technician found leak to be coming from cylinder#1 wall and bottom plate.Exchange paperwork was created and submitted.No repair checklist was required as per crm.An exchange for the new cart was scheduled.New carts (serial number: (b)(4)) were shipped from (b)(6) to the hospital.On 6 nov 2017, the new carts were confirmed to have been delivered to the hospital and (b)(6) surgery ct was dispatched a service technician to the site to perform exchange.On 9 nov 2017, 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 as per crm.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 (confirmation number: (b)(4)).The exchange cart was confirmed to have been returned to riverside on 15 nov 2017 and the unit was refurbished as per the details from a returned equipment log.The root cause of the reported event was due to damaged bottom plate.The reported event was confirmed during inspection of the device and the issue was resolved with an exchange.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: 7070905
• MDR Text Key: 93810199
• Report Number: 0001954182-2017-00039
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• 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: N/A
• Other Device ID Number: (01)00880924405092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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