MAUDE Adverse Event Report: AVANOS MEDICAL INC. 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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30020175 was reviewed and the product was produced according to product specifications.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
Fill volume: 100 ml.Flow rate: 2ml/hour.Procedure: chemotherapy/5fu.Cathplace: unknown.Infusion start time: 1:30pm, (b)(6) 2020.Infusion stop time: (b)(6) 2020 "middle of the night".It was reported that the patient had a pump with 5fu (fluorouracil) placed on (b)(6) 2020 at 1:30pm, with an intended pump completion/removal on (b)(6) 2020 at 11am, for a total delivery time of 46 hours.The customer returned to the office on (b)(6) 2020 at 9am, reporting that the pump had gone empty "in the middle of the night." the pump was described as "flat when the nurses dc'd [disposed of in hazardous materials waste] it".The customer was described as an "experienced user.".

• Brand Name: HOMEPUMP C-SERIES, 100 ML, 2 ML/HR (CONTAINS DEHP)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10543481
• Report Number: 2026095-2020-00118
• Device Sequence Number: 11540657
• Product Code: MEB
• UDI-Device Identifier: 00193494135614
• UDI-Public: 00193494135614
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/16/2020

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: 06/12/2022
• Device Model Number: C100020
• Device Catalogue Number: 101356106
• Device Lot Number: 30020175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/16/2020
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 73