MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 600 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number	CB6004
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 actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 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 (b)(6) 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 (b)(6) medical, inc.(b)(6) 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 (b)(6) medical, inc.Complaint database and identified as complaint (b)(4).The device was not returned.
Event or Problem Description
Fill volume: 750 ml, flow rate: 8ml/hr, procedure: unknown, cathplace: unknown.It was reported a fast flow event occurred.The device emptied earlier than expected.The pump emptied prior to 48-hours and was never increased above rate of 8ml/hr.No additional information was provided.

• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7860793
• Report Number: 2026095-2018-00092
• Device Sequence Number: 1986858
• Product Code: MEB
• UDI-Device Identifier: 30680651134760
• UDI-Public: 30680651134760
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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 Model Number: CB6004
• Device Catalogue Number: 101347603
• 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: 08/15/2018
• Initial Report FDA Received Date: 09/10/2018
• Patient Sequence Number: 1