MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP ECLIPSE ELASTOMERIC PUMP, 100 ML, 200 ML/HR (DEHP-FREE); NON-DEHP PUMP - HFR

Model Number	SE102000-10
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: 100 ml.Flow rate: 200 ml.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the pump inflated on the side and the infusion passed in less than 15 minutes.The pump was placed next to the infusion site.The patient tolerated it well.No injury or medical interventions reported.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.Information reasonably known as of 18 jan 2023 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 reported event but is relaying the information 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.
Additional Manufacturer Narrative
The device history record for lot 20077285 was reviewed and the product was produced according to product specifications.All information reasonably known as of(b)(6) 2023 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 reported event but is relaying the information 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)(6).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 ECLIPSE ELASTOMERIC PUMP, 100 ML, 200 ML/HR (DEHP-FREE)
• Common Device Name: NON-DEHP PUMP - 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: 16236979
• Report Number: 2026095-2023-00003
• Device Sequence Number: 6992729
• Product Code: MEB
• UDI-Device Identifier: 00193494348915
• UDI-Public: 00193494348915
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2023

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: Other
• Device Expiration Date: 03/27/2024
• Device Model Number: SE102000-10
• Device Catalogue Number: N/A
• Device Lot Number: 20077285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NULOJIX
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 65 KG