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	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is in-progress.All information reasonably known as of 03 jun 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
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 2026095-2020-00082 for the second report fill volume: 201 ml, flow rate: 2 ml/hr, procedure: chemotherapy, cathplace: unknown, infusion start time: (b)(6) 2020, 0904, infusion stop time: (b)(6) 2020, 0900.It was reported that the patient experienced fast flow with a pump filled with saline and 5fu[fluorouracil]."states pump filled with 201cc in an effort to achieve a 96 hour delivery rate, per ifu filling table, but patient returned back to clinic one day early.No injury or symptoms." pharmacist stated they routinely add heparin 4000 units to the 5fu/saline pumps that infuse over 4-7 days.Additional information received 15-may-2020 indicated "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." pump was located outside patient clothing or blanket, flow restrictor was taped to patient's skin, pump is below the catheter, and tubing was located under patient clothing or blanket.Device was stored at room temperature and environmental conditions during infusion were room temperature.
Additional Manufacturer Narrative
The device history record for lot 0002970711 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.A photo of the pump was provided; however, it is not possible to confirm the reported event based on the photo.Root cause could not be determined.All information reasonably known as of 31 jul 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: 10121415
• Report Number: 2026095-2020-00081
• Device Sequence Number: 2309710
• 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): 08/03/2020

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: 05/14/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 08/03/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLUOROURACIL; HEPARIN; SALINE
• Patient Age: 59 YR
• Patient Weight: 70