MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q SYSTEM SAF&ONDEMAND 400MLX2-14ML/H; ELASTOMERIC - COMBO

Model Number CB006

Device Problems Excess Flow or Over-Infusion (1311); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 16 jun 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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 complaint database and identified as complaint comp(b)(4).

Event Description

Fill volume: 550ml.Flow rate: 6ml/hr.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the customer failed to remove the red tab on the bolus button, resulting in higher than expected flow rates.Per additional information received 10 jun 2020, the infused drug was 0.2% ropivacaine.The pump had infused in 18 hours, when it should have lasted 91.66 hours.The patient did not experience any side effects.The pump use was discontinued and the catheter was pulled.The doctor prescribed additional pain medication for the patient.

Event Description

Per additional information rec'd 26 jun 2020: procedure: right knee arthroscopy with anterior cruciate ligament reconstruction with partial meniscus repair; infusion start time: approx 14:30; infusion stop time: pt reported out at 12:00 the following day- less than 24hours.Per additional information received 30 jun 2020, the pump was a new one to the customer and they had not received in-service training on it.The customer has since received training on how to remove the red tab.

Manufacturer Narrative

No sample was returned for evaluation, however, based on the information provided, the root cause has been determined to be "incorrect use." all information reasonably known as of 23 jul 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.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 complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: ON-Q SYSTEM SAF&ONDEMAND 400MLX2-14ML/H
• Type of Device: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10174256
• MDR Text Key: 241007125
• Report Number: 2026095-2020-00105
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

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: Lay User/Patient
• 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: 06/04/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/24/2020
• Patient Sequence Number: 1