MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE 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 Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
He actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 02-jan-2020 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 three different incidences, which were associated with separate units, involving three different events.This is the third of three reports.Refer to 2026095-2020-00001 for the first event.Refer to 2026095-2020-00002 for the second event.Fill volume: 100ml.Flow rate: 5 ml/hr.Procedure: unknown.Cathplace: unknown.Infusion start time: (b)(6) 2019 at 11:12 infusion end time: (b)(6) 2019 03:00 it was reported in the third cycle of chemotherapy of the patient day-2, the infusion pump completed the infusion in 16-hours instead of 20-hours.There was no reported patient injury nor medical intervention required.
Additional Manufacturer Narrative
Correction: the actual complaint product was not returned for evaluation.The device history record for the reported lot number, 0202916602, 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 19-mar-2020 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.

• Brand Name: HOMEPUMP C-SERIES, 125 ML, 5 ML/HR (CONTAINS DEHP)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9546157
• Report Number: 2026095-2020-00003
• Device Sequence Number: 14236796
• Product Code: MEB
• UDI-Device Identifier: 10680651135633
• UDI-Public: 10680651135633
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 08/01/2020
• Device Model Number: C125050
• Device Catalogue Number: 101356302
• Device Lot Number: 0202916602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FU/2500MG
• Patient Age: 64 YR
• Patient Weight: 79