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

Model Number	C100020
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.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 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.
Event or Problem Description
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the first of two reports.Refer to 2026095-2020-00061 for the second report.Fill volume: 95ml, flow rate: 2ml/hr, procedure: 5fu, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.It was reported that the pump of 5fu ran empty after a day instead of the expected 48 hours.The patient has alleged she keeps the pump in a safe spot next to her at night and does not sleep on it.There was no injury to the patient.
Additional Manufacturer Narrative
The device history record for lot 0203018613 was reviewed and the product was produced according to product specifications.All information reasonably known as of 21 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 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.
Event or Problem Description
Per additional information received from the pharmacist on 8 may 2020, the pump was actually not empty, and that the patient had not reported the incident correctly to the pharmacist originally.Per additional information received from the pharmacist on 12 may 2020, the pharmacist still confirms that there were two fast flow incidents.

• Brand Name: HOMEPUMP C-SERIES, 100 ML, 2 ML/HR (CONTAINS DEHP)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9988951
• Report Number: 2026095-2020-00060
• Device Sequence Number: 11736464
• Product Code: MEB
• UDI-Device Identifier: 10680651135619
• UDI-Public: 10680651135619
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2020

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: Lay User/Patient
• Device Expiration Date: 01/01/2021
• Device Model Number: C100020
• Device Catalogue Number: N/A
• Device Lot Number: 0203018613
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FU