MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PUMP WITH ONDEMAND; CATHETERS

Model Number	PS12504
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for lot 0202775489 was reviewed and the product was produced according to product specifications.Root cause could not be determined.All information reasonably known as of 06 may 2019 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: unknown, flow rate: unknown, procedure: breast surgery, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving the same patient.This is the second of three reports.Refer to 2026095-2019-00078 for the first report.Refer to 2026095-2019-00080 for the third report.It was reported that a fast flow event occurred.Three units are involved.No injury was reported.

• Brand Name: ON-Q PUMP WITH ONDEMAND
• Common Device Name: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8584454
• Report Number: 2026095-2019-00079
• Device Sequence Number: 1942243
• Product Code: MEB
• UDI-Device Identifier: 30680651136467
• UDI-Public: 30680651136467
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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 Expiration Date: 01/26/2020
• Device Model Number: PS12504
• Device Catalogue Number: 101364600
• Device Lot Number: 0202775489
• 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: 04/16/2019
• Initial Report FDA Received Date: 05/06/2019
• Patient Sequence Number: 1