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

Model Number	E102000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Rash (2033); Peripheral Nervous Injury (4414)
Date of Event	05/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 12 jul 2021 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.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).
Event or Problem Description
Fill volume: 103ml.Flow rate: 200ml/hr.Procedure: unknown.Catheter placement: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported via mw5101625 that "patient had rash, nausea, and facial dysesthesia." per additional information received 9 jul 2021, "patient is a (b)(6) year old (b)(6) kg male treated with ceftriaxone.Patient is stable.The eclipse size used was 200 ml/hr 100 ml.Device was filled with 83 ml of sodium chloride 0.9% solution, primed, then 20 ml of ceftriaxone was added to the device.The device was discarded by the patient caregiver." additional information has been requested but not yet received.

• Brand Name: AVANOS HOMEPUMP ECLIPSE AMBULATORY INFUSION SYSTEMS
• Common Device Name: ELASTOMERIC HFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12162456
• Report Number: 2026095-2021-00076
• Device Sequence Number: 4052829
• Product Code: MEB
• UDI-Device Identifier: 00193494135515
• UDI-Public: 00193494135515
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: E102000
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• 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: 06/22/2021
• Initial Report FDA Received Date: 07/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 15 YR
• Patient Weight: 42