MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES; ELASTOMERIC LFR

Model Number	C270020
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 0002970711 was reviewed and the product was produced according to product specifications.The investigation is in progress.All information reasonably known as of 27 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 (b)(4).Device not returned.
Event or Problem Description
Fill volume: 201 ml, flow rate: 96 ml/hr, procedure: chemotherapy , cathplace: unknown, infusion start time: 04-may-2020 11:00, infusion stop time: (b)(6) 2020 09:00.It was reported that the patient's pump "finished about 1 day earlier than it was supposed to." "patient had pump attached on (b)(6) 2020, then presented to infusion center 1 day early as the pump appeared to be completely empty.The nurse corroborated that all connections, clamps, etc.Were connected properly and appeared to be in working order.The patient will return to the infusion clinic for re-treatment with a new pump next monday." no patient injury was reported.Patient was educated on how to use the device; it was the patient's ninth time using this style pump.Additional information was received 22-may-2020 as fda medwatch/ fda user facility report mw5094439.The report states "patient had halyard c elastomeric pump attached for 5-fluorouracil extended infusion on [date redacted], then presented to infusion center 1 day early as the pump appeared to be completely empty.The nurse corroborated that all connections, clamps, etc.Were connected properly and appeared to be in working order.The patient will return to the infusion clinic for re-treatment with a new pump next (b)(6).Fda safety report id [number redacted].".
Event or Problem Description
Flow rate is 96 hours, not 96 ml/hr.
Additional Manufacturer Narrative
Corrected data: b5: flow rate is 96 hours, not 96 ml/hr.Use review indicated pump was filled in accordance with the instructions, pump was used at normal room temperature and was above clothes or blankets, customer is not considered new or inexperienced, and the medication is not a contributor to the incident.The actual complaint product was not returned for evaluation.Photos were provided by the customer; however, it is not possible to identify a root cause based on the photos.No root cause was identified.All information reasonably known as of (b)(6) 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
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 10097230
• Report Number: 2026095-2020-00072
• Device Sequence Number: 3407358
• Product Code: MEB
• UDI-Device Identifier: 10680651135664
• UDI-Public: 10680651135664
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/25/2020

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: 07/28/2021
• Device Model Number: C270020
• Device Catalogue Number: 101356604
• Device Lot Number: 0002970711
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/25/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLUOROURACIL 20.4MG/ML
• Patient Age: 59 YR
• Patient Weight: 71