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

Model Number	C270020
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Fatigue (1849); Nausea (1970); No Code Available (3191)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 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.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: 201ml.Flow rate: 2ml/hr.Procedure: chemotherap.Cathplace: unknown.It was reported a pump set at 2 ml/hr for 96-hours but the device infused over about 48 hours.The pump was intended to be initiated on monday and removed on friday.The patient reported to the clinic on thursday afternoon stating that the pump was completely empty sometime wednesday night.The patient experienced symptoms of "fast flow" and the clinic treated the pateint with "hydration".Additional information received 24-feb-2020 noted the pharmacist stated the patient experienced "neurologic symptoms," nausea, mouth sores and fatigue.The patient returned today for hydration and will continue to be monitored until the next chemotherapy cycle which is due on b)(6) 2020.
Additional Manufacturer Narrative
The device history record for the reported lot number, 0002963600, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was received empty.The device was evaluated for flow and pressure and testing.The evaluation concluded the device was within specifications.The failure was not confirmed.A root cause was not identified.All information reasonably known as of 26-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).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, 270 ML, 2 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: 9858054
• Report Number: 2026095-2020-00040
• Device Sequence Number: 2663779
• Product Code: MEB
• UDI-Device Identifier: 10680651135664
• UDI-Public: 10680651135664
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 01/17/2021
• Device Model Number: C270020
• Device Catalogue Number: 101356604
• Device Lot Number: 0002963600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FU (6760MG) /NS.
• Patient Weight: 59