MAUDE Adverse Event Report: AVANOS- IRVINE ON-Q* C-BLOC INTL PAIN RELIEF SYSTEM, 400 ML, 10 ML/HR; ELASTOMERIC LFR

Model Number	CBI002
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 31 oct 2018 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: 420 ml.Flow rate: 10 ml/hr.Procedure: knee prosthesis.Cathplace: knee intra-articular catheter.Infusion start time: unknown.Infusion stop time: unknown.It was reported that after 30 hours, the pump was empty.There was no adverse event related to the event.

• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS- IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8044223
• Report Number: 2026095-2018-00123
• Device Sequence Number: 1188074
• Product Code: MEB
• UDI-Device Identifier: 30680651134791
• UDI-Public: 30680651134791
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: Other
• Device Model Number: CBI002
• Device Catalogue Number: 101347902
• 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: 10/10/2018
• Initial Report FDA Received Date: 11/06/2018
• Patient Sequence Number: 1