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

Catalog Number 00514010100

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The previous repair record for intellicart system 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 repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) hospital that an intellicart unit had a power iv pole that was fully extended and would not retract.On (b)(6) 2019, moore's electrical & mechanical construction, inc was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site on 24 january 2019 and found that the iv pole had spun in place, and in doing so tore the wires from the plugs and pulled the plugs free from the main control board.The technician determined that both the iv pole and the main control board would need to be replaced.On 28 january 2019, the technician returned and replaced the main control board (part #70064 and lot code #0028813) and installed a new power iv pole (part #00-5140-102-00), then verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.The device was tested, inspected, and repaired as per cl ¿ repair cart and evac rev.0.Service work order (b)(4) on 21 january 2019.Based on the information available, the root cause for the power pole being unable to retract was due to the pole rotating enough to both tear its wires and remove itself from power.If the iv pole is able to spin freely during use, it can do so enough that it can damage itself and be unable to be raised or lowered as well as cause damage to other components like the main control board, such as in the reported event.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power iv pole and main control board were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

It was reported that the unit had a power iv pole that was fully extended and cannot retract it.The event timing was before surgery.Investigation showed frayed wires.No adverse events were reported as a result of this 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: 8387296
• MDR Text Key: 137849340
• Report Number: 0001954182-2019-00020
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2019

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: 00514010100
• Device Lot Number: 0023808
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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