MAUDE Adverse Event Report: AVANOS MEDICAL INC. AVANOS HOMEPUMP ECLIPSE AMBULATORY INFUSION SYSTEMS; ELASTOMERIC HFR

Model Number E101000

Device Problem Infusion or Flow Problem (2964)

Patient Problems Fatigue (1849); Nausea (1970); Peeling (1999); Vomiting (2144)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

Fill volume: 100 ml, flow rate: 100 ml/hr, procedure: treatment, cathplace: mediport, infusion start time: unknown, infusion stop time: unknown.Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the second of two reports.Refer to 2026095-2022-00019 for the first report.It was reported that a 100 milliliter/hour (ml/hr) pump was used for a 46 hour infusion, when usually a 2ml/hr pump is used.The patient received 5fu (fluorouracil) infusion over 2 hrs instead of 46 hrs.The patient complained of increased nausea/vomiting, hand and foot peeling and increased fatigue.There was no report of medical intervention.Additional information received 03mar2022 reported that there was a 1 week delay on next treatment and extra anti-nausea meds given and the patient has returned to baseline.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 22 mar 2022 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.

Manufacturer Narrative

A review of the information provided determined that the clinician used the eclipse pump instead of the c-series pump therefore; the incident is not related to a product malfunction nor to the manufacturing process but with an incorrect use of the device.The complaint cannot be confirmed as reported.The device history record for lot 20073495 was reviewed and the product was produced according to product specifications.All information reasonably known as of 29 apr 2022 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.

• Brand Name: AVANOS HOMEPUMP ECLIPSE AMBULATORY INFUSION SYSTEMS
• Type of Device: ELASTOMERIC HFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13874798
• MDR Text Key: 297629292
• Report Number: 2026095-2022-00020
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 20193494135496
• UDI-Public: 20193494135496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2024
• Device Model Number: E101000
• Device Catalogue Number: N/A
• Device Lot Number: 20073495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 5FU FLUOROURACIL
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 57 KG