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	Pain (1994)
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 0203135253 was reviewed and the product was produced according to product specifications.All information reasonably known as of 20 jun 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: unknown flow rate: 8ml/hr ; procedure: medial patellofemoral ligament (mpfl) reconstruction with graft; cathplace: unknown; infusion start time: unknown; infusion stop time: unknown.It was reported that "pump was connected at 8mls/hr on (b)(6) [2019] and completely ran out of medication in 16 hrs, therefore in ran at about 25mls/hr.Pump was discontinued and removed.Patient was fine and had no injuries or local toxicity issues but pain came right back once pump was empty.According to [the physician] the pump was not leaking and nothing in the area seemed to be wet.".
Event or Problem Description
Additional information received 23-aug-2019 indicated "just spoke to [physician].The pump ran dry after 16-17 hours.Set at 8cc per hour.Patient never came back for post op appointment and they have been unable to get the pump.".
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 16 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: 8725006
• Report Number: 2026095-2019-00122
• Device Sequence Number: 16699440
• Product Code: MEB
• UDI-Device Identifier: 10680651134728
• UDI-Public: 10680651134728
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

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: 06/08/2021
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: 0203135253
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/18/2019
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 57