MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES ELASTOMERIC PUMP, 100 ML, 2 ML/HR (DEHP-FREE); ELASTOMERIC LFR

Model Number	C100020-10
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
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 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 04-mar-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).
Event or Problem Description
Fill volume: 89 ml, flow rate: unknown, procedure: unknown, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that the pump was filled with 89 ml of 5fu for a duration of 44.5 hours.The pump completed 7 hours prior to the expected completion time.No patient injury reported.

• Brand Name: HOMEPUMP C-SERIES ELASTOMERIC PUMP, 100 ML, 2 ML/HR (DEHP-FREE)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8394265
• Report Number: 2026095-2019-00037
• Device Sequence Number: 18880282
• Product Code: MEB
• UDI-Device Identifier: 30680651348945
• UDI-Public: 30680651348945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 02/14/2019

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: Other
• Device Expiration Date: 12/06/2019
• Device Model Number: C100020-10
• Device Catalogue Number: 103489404
• Device Lot Number: 0008033161
• 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: 02/14/2019
• Initial Report FDA Received Date: 03/06/2019
• Patient Sequence Number: 1