MAUDE Adverse Event Report: AVANOS MEDICAL, INC. HOMEPUMP C-SERIES*, 125 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number	C125050
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.The device history record for the reported lot number, 0202928272, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 21-nov-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 avanos medical, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the second of two reports.Refer to 2026095-2018-00151 for the first event.Fill volume: unknown.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.It was reported a fast flow event occurred and the device worked in less time than indicated.There was no reported injury.No additional information was provided.
Additional Manufacturer Narrative
The correct lot# for this fast flow event was 0202928272.The device history record for the reported lot number, 0202928272, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of (b)(6) 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 avanos medical, inc.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 actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided and confirmed the reported incident.A root cause was not identified.All information reasonably known as of 21-jul-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 avanos medical, inc.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.

• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8097589
• Report Number: 2026095-2018-00152
• Device Sequence Number: 2025298
• Product Code: MEB
• UDI-Device Identifier: 30680651135637
• UDI-Public: 30680651135637
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2020

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: 08/15/2020
• Device Model Number: C125050
• Device Catalogue Number: 101356304
• Device Lot Number: 0202928272
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 02/07/2019; 07/08/2020
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 02/25/2019; 07/22/2020
• Patient Sequence Number: 1