MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; 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 02/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k): k081047; k123188; k133786.This medwatch is being filed to relay additional information.The following sections were it was reported from (b)(6) hospital that a unit was setting off the or electrical panel alarm with leakage >1000ma.On 27 february 2018, replite was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and found current leakage caused by damaged fan that was damaged from a valve pack leak.He replaced the fan reseated the valve pack, and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.The device was tested, inspected, and repaired.The root cause for the unit setting off the or electrical panel alarm was due to current leakage from a damaged fan, which was caused by a leaking valve pack.Fluid would damage the electrical circuits of the fan unit, leading to current leakage, which in turn would trip the electrical panel alarm.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the valve pack was reseated and the fan was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Evaluated by external service technician.

Event Description

It was reported that the ultra duo high fluid cart was setting off the or electrical panel.It stated that fluid was leaking during surgery.No adverse events were reported as a result of this malfunction.

• Brand Name: ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
• 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: 7351341
• MDR Text Key: 102862586
• Report Number: 0001954182-2018-00020
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PSEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2018

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: ULDU500
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2014
• 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