MAUDE Adverse Event Report: AVANOS- IRVINE HOMEPUMP C-SERIES*, 270 ML, 2 ML/HR (CONTAINS DEHP); NON-DEHP PUMP - LFR

Model Number	C270020
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2018
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 0202785277 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 aug 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 halyard health 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 halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
Event or Problem Description
Fill volume: unknown.Flow rate: 2 ml/hour.Procedure: unknown.Cathplace: chest port.Infusion start time: unknown.Infusion stop time: (b)(6) 2017.It was reported that the patient's fluorouracil infusion pump infused over three days instead of the expected four days (96 hours).No injury to the patient reported.No further information provided.

• Common Device Name: NON-DEHP PUMP - LFR
• Manufacturer (Section D): AVANOS- IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7766895
• Report Number: 2026095-2018-00085
• Device Sequence Number: 181922
• Product Code: MEB
• UDI-Device Identifier: 30680651135668
• UDI-Public: 30680651135668
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2018

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: 02/07/2020
• Device Model Number: C270020
• Device Catalogue Number: 101356604
• Device Lot Number: 0202785277
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/09/2018
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Weight: 90