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

Model Number	CB004
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0203137257 was reviewed and the product was produced according to product specifications.All information reasonably known as of 04 sep 2019 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
Fill volume: 400 ml.Flow rate: 6 ml/hr.Procedure: tibia/fibula fracture/achilles tendon repair.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the "pump [was] empty after 2 days of infusion.Saf [select-a-flow] set to 6 ml/hr.Patient stable with no s/s [signs/symptoms] of local toxicity." "pump at 6 ml/hr for the duration of the infusion ropivacaine 0.2%.Patient had no side effects, no ringing in ears, no metal taste in mouth, no tachycardia.Patient says he was told to remove the pump on sunday but early on saturday noticed the pump looked empty.Patient confirmed it is empty.".
Additional Manufacturer Narrative
The device was evaluated.The evaluation summary concluded the pump's distal end infused with the attached catheter when all selectable flow rates were selected during infusion verified.All tested rates met specification.The failure was not confirmed.The root cause was not identified.All information reasonably known as of 20-nov-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.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.The investigation is in progress.All information reasonably known as of 30 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: 8964398
• Report Number: 2026095-2019-00149
• Device Sequence Number: 11273061
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2019

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: Lay User/Patient
• Device Expiration Date: 06/16/2021
• Device Model Number: CB004
• Device Catalogue Number: 101347203
• Device Lot Number: 0203137257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/17/2019
• Supplement Date Received by Manufacturer: 09/05/2019; 10/31/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/01/2019; 11/21/2019
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 134