MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number CB006

Device Problems Improper or Incorrect Procedure or Method (2017); Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause was identified as incorrect use due to the customer statement that the red tab was not removed from the pump.The product was not used in accordance with the instructions for use as a fast flow will be observed in the pump if the red tab is not removed.All information reasonably known as of 01 jun 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 500 ml, flow rate: unknown, procedure: knee replacement, cathplace: adductor canal block, infusion start time: (b)(6) 2021, time not provided.Infusion stop time:(b)(6) 2021, 0800.It was reported that the device delivered local anesthetic at a fast flow rate.The pump was set up for a continuous, surgeon-placed adductor canal block and when checked on the morning of (b)(6) 2021 was found to be almost depleted.The pump was filled to 500ml, however the red tab was not removed.It was identified that a new nurse set up the pump the day prior.The pump was clamped when the fast flow was identified.No patient harm was reported.Additional information received 13-may-2021 indicated the site has been using on-q since 2013, and the on demand model since 2018.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Type of Device: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11938245
• MDR Text Key: 280678906
• Report Number: 2026095-2021-00063
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494134747
• UDI-Public: 00193494134747
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial
• Report Date: 06/04/2021

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: CB006
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1