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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The device history record for lot 0202747607 was reviewed and the product was produced according to product specifications.All information reasonably known as of 30 oct 2018 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
Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units.This is the third of four reports.Refer to 2026095-2018-00116 for the first report.Refer to 2026095-2018-00117 for the second report.Refer to 2026095-2018-00119 for the fourth report.It was reported there was an over-infusion event.No further information has been provided at this time.
Additional Manufacturer Narrative
Sample evaluation was performed.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 400 ml.The sample was evaluated and the reported event could not be confirmed.Limited information was provided regarding use conditions, therefore, it is not possible to determine if product was used in accordance with the instructions or if user or facility contributed to the reported incident.No medication information was provided to determine if the product contributed to the incident of fast flow.Root cause could not be determined.All information reasonably known as of 09-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 halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: ON-Q C-BLOC INTL PAIN RELIEF SYSTEM, 400 ML, 10 ML/HR
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8044141
• Report Number: 2026095-2018-00118
• Device Sequence Number: 11121608
• Product Code: MEB
• UDI-Device Identifier: 30680651134791
• UDI-Public: 30680651134791
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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 Expiration Date: 12/21/2019
• Device Model Number: CBI002
• Device Catalogue Number: 101347902
• Device Lot Number: 0202747607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 01/10/2019
• Patient Sequence Number: 1