MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS, 270 ML; ELASTOMERIC LFR

Model Number	PS6505-A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
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 five different incidences, which were associated with separate units, involving five different patients.This is the first of five reports.Refer to 2026095-2020-00087 for the second report.Refer to 2026095-2020-00088 for the third report.Refer to 2026095-2020-00089 for the fourth report.Refer to 2026095-2020-00090 for the fifth report.Fill volume: 330 ml, flow rate: 4 ml/hr, procedure: cardiac surgery, cathplace: subcutaneous, lateral to either side of the sternum.Infusion start time: (b)(6) 2019 16:20 infusion stop time: (b)(6) 2019 10:00 it was reported that a fast flow event occurred; the dosage was delivered 25% faster than expected.No patient injury was reported.Additional information received 27-may-2020 indicated "single use elastomeric device filled with local anesthetic solution infused faster than expected.The [device] was used after cardiac surgery.This is a dual catheter device and was placed by the surgeons either side of the sternotomy wound.The pump was filled with 330mls of levobupivacaine 0.125% as per hospital guidelines, this is the maximum fill volume for this pump.The pump was connected and commenced infusion at 16:20 on (b)(6) 2019 at rate of 4ml/hr and was expected to run for 82.5 hours, it was noticed to be empty at 10:00 on the (b)(6) 2019 which meant it had delivered in 66.5 hours equaling 5ml/hr or 25% faster than expected." additional information has been requested but not yet received.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS, 270 ML
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10135340
• Report Number: 2026095-2020-00086
• Device Sequence Number: 11524311
• Product Code: MEB
• UDI-Device Identifier: 00193494136307
• UDI-Public: 00193494136307
• 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: PS6505-A
• Device Catalogue Number: 101363003
• 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
• Patient Age: 3 YR
• Patient Weight: 16