MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES; ELASTOMERIC LFR

Model Number	C270010
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 14 may 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
Fill volume: 270 ml, flow rate: 1 ml/hr, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that "the pump has run empty too quickly.The pump had already run out after two days.Filling volume was 270 ml all according to the instructions." no patient injury was reported.The pump was filled with 5fu [fluorouracil].
Additional Manufacturer Narrative
The device history record for lot 0203023426 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.No defect was found related with fast flow.Root cause could not be determined.All information reasonably known as of 22 jun 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
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10062105
• Report Number: 2026095-2020-00065
• Device Sequence Number: 3573882
• Product Code: MEB
• UDI-Device Identifier: 30680651135651
• UDI-Public: 30680651135651
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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: Lay User/Patient
• Device Expiration Date: 12/22/2020
• Device Model Number: C270010
• Device Catalogue Number: 101356504
• Device Lot Number: 0203023426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 06/25/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FU - FLUOROURACIL.