MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PUMP WITH SELECT-A-FLOW; ELASTOMERIC - SAF

Model Number	CB6007
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
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.Root cause could not be determined.The device history record for lot 0203088358 was reviewed and the product was produced according to product specifications.All information reasonably known as of 11 sep 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.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: 600 ml, flow rate: 7 ml/hr, procedure: pediatric cardiac, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that the patient's pump, filled with 600ml local anesthetic solution, ran through in under 30 hours when it was expected to fun for 42 hours at 7ml/hr/catheter."investigations and discussions with the staff filling and checking the device in theatre (nursing and anesthetic staff) suggests it is unlikely to be an under-fill issue due to the robust process employed on a regular basis however it cannot be ruled out completely.Investigations of care given while in picu [pediatric intensive care unit] and 10b appear all appropriate." no patient adverse effects reported.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
The device history record for the reported lot number,0203088358, 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 27-sep-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 PUMP WITH SELECT-A-FLOW
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9024770
• Report Number: 2026095-2019-00150
• Device Sequence Number: 19396794
• Product Code: MEB
• UDI-Device Identifier: 10680651134773
• UDI-Public: 10680651134773
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 03/18/2021
• Device Model Number: CB6007
• Device Catalogue Number: 101347704
• Device Lot Number: 0203088358
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 11/27/2019
• Patient Sequence Number: 1