MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number	CB004
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 0002990506, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.All information reasonably known as of 24-oct-2019 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.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 eight different incidences, which were associated with separate units, involving eight different events.This is the first of eight reports.Refer to 2026095-2019-00167 for the second event.Refer to 2026095-2019-00168 for the third event.Refer to 2026095-2019-00169 for the fourth event.Refer to 2026095-2019-00170 for the fifth event.Refer to 2026095-2019-00171 for the sixth event.Refer to 2026095-2019-00172 for the seventh event.Refer to 2026095-2019-00173 for the eighth event.Fill volume: 400 ml flow rate: 4ml/hr-6ml/hr procedure: continuous peripheral nerve blocks for surgical procedures.Cathplace: unknown it was reported the pump was running out of medication earlier than expected.The device lasted roughly 36-hours to 37-hours versus the 72-hours it should have lasted." there was no reported patient injury reported.Additional information received 14-oct-2019 stated, "we do educate the patients on the pain pumps as well as send them home with written instructions regarding it.Typically the anesthesiologist have them leave the surgery center with the pump set at 4-6ml hour.We instruct the patients to leave them there unless having increased pain, then they can turn up to 10-14ml for one hour then turn back down.We call our patient¿s every day until the pump is removed asking them questions about what the rate is set at and pain levels.Patients are instructed to take po pain medications as well from the time they leave." the patient reports not turning the pump rates up during its duration.There was no reaction reported.The pump was hooked up to the patient and started in post anesthesia care unit( pacu) post procedure and typically the patient leaves the center within 2-hours of surgery.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9240850
• Report Number: 2026095-2019-00166
• Device Sequence Number: 1611277
• Product Code: MEB
• UDI-Device Identifier: 10680651134728
• UDI-Public: 10680651134728
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

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: 11/10/2021
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 0002990506
• 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: 10/01/2019
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR