MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q ELASTOMERIC PUMP, 270 ML X 4 ML/HR (2 ML/HR + 2 ML/HR), DUAL SITES; ELASTOMERIC LFR

Model Number	P270X4D
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 0202988330 in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 16-jan-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.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, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: 270 ml.Flow rate: unknown.Procedure: abdominoplasty.Cathplace: unknown.Date/time infusion start: (b)(6) 2019 at 1:00pm, date/time infusion stop: 48-hours after surgery (b)(6) 2019.It was reported a fast flow event occurred.Additional information received (b)(6) 2019 stated the operating room (or) nurse "cut off the white clips and disposed of the pump".The patient reported that the device infused in 48-hours.Additional information received (b)(6) 2019 stated the device was carried in on-q bag secured the around patient's waist.Additional information received (b)(6) 2019 stated the pump was filled "the before or the morning of the same day of use".There was no reported injury.

• Brand Name: ON-Q ELASTOMERIC PUMP, 270 ML X 4 ML/HR (2 ML/HR + 2 ML/HR), DUAL SITES
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8259314
• Report Number: 2026095-2019-00010
• Device Sequence Number: 19291073
• Product Code: MEB
• UDI-Device Identifier: 30680651136726
• UDI-Public: 30680651136726
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/28/2018

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: 10/23/2020
• Device Model Number: P270X4D
• Device Catalogue Number: 101367203
• Device Lot Number: 0202988330
• 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: 12/28/2018
• Initial Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1