MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW VARIABLE RATE CONTROLLER; ELASTOMERIC - SAF

Model Number	SAF01
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 could not be determined.All information reasonably known as of 09 jun 2020 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 or Problem Description
Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 2026095-2020-00092 for the second report.Refer to 2026095-2020-00093 for the third report.Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that a fast flow event occurred; the total infusion time was 18-22% faster than expected.No patient injury was reported.Additional information has been requested but not yet received.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW VARIABLE RATE CONTROLLER
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10135745
• Report Number: 2026095-2020-00091
• Device Sequence Number: 3044928
• Product Code: MEB
• UDI-Device Identifier: 00193494136109
• UDI-Public: 00193494136109
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2020

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
• Operator of Device: Health Professional
• Device Model Number: SAF01
• Device Catalogue Number: 101361003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1