MAUDE Adverse Event Report: AVANOS- IRVINE ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO DEVICE PRODUCT CODE

Model Number	CBI006
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 0202802229 was reviewed and the product was produced according to product specifications.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 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: 200 ml, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.Avanos medical inc.Received a single report that referenced four different incidences, which were associated with separate units, involving four different patients.This is the third of four reports.Refer to 2026095-2018-00112 for the first report.Refer to 2026095-2018-00113 for the second report.Refer to 2026095-2018-00115 for the fourth report.It was reported that there was a fast flow event.It was alleged that the pump was filled with 200ml and finished 3 hour and 30 minutes faster than expected.No further information has been provided.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - COMBO DEVICE PRODUCT CODE
• Manufacturer (Section D): AVANOS- IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8008995
• Report Number: 2026095-2018-00114
• Device Sequence Number: 10805592
• Product Code: MEB
• UDI-Device Identifier: 30680651134838
• UDI-Public: 30680651134838
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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: 09/05/2019
• Device Model Number: CBI006
• Device Catalogue Number: 101348303
• Device Lot Number: 0202802229
• 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: 10/01/2018
• Initial Report FDA Received Date: 10/26/2018
• Patient Sequence Number: 1