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

Catalog Number ULDU100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record (dhr) for ultra duofluid cart serial number (b)(4) was reviewed and 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.On (b)(6) 2019, it was reported from (b)(6) hospital that a duo cart unit was showing the cylinder was full when it was empty.On (b)(6) 2019, drmet biomedical llc was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed that fluid was not registering properly in either cylinder of the unit.The technician replaced both level sensors (part #91584 and lot code #0028645) and 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 rev.4.Service work order dms-51660-w5m3g3 on 07 may 2019.The root cause for the unit showing incorrect fluid levels was due to malfunctioning level sensors in both cylinders.The level sensor reports fluid levels in the unit; malfunctioning level sensors would result in the incorrect fluid readings reported and could also cause errors to be issued.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after both level sensors 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 both units on the cylinder show full when it was empty.The event timing was after surgery.There was no patient involvement and 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: 8616121
• MDR Text Key: 145261472
• Report Number: 0001954182-2019-00034
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULDU100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2011
• 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