MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (DEHP); ELASTOMERIC LFR

Model Number	C270050
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Malaise (2359); Angioedema (4536); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: health effect - clinical code/no code: hair loss in abundant quantities (alopecia) 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 06-sep-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 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.H3 other text : device not returned.
Event or Problem Description
Fill volume: 270ml flow rate: 5ml/hr procedure: chemotherapy cathplace: unknown it was reported the pump infused sooner than expected (12 hours and not 44 hours), and the patient presented with unspecified symptoms.The patient experienced general malaise, edema in the face and hair loss in abundant quantities.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30225018, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 02-nov-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 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, 270 ML, 5 ML/HR (DEHP)
• Common Device Name: ELASTOMERIC LFR
• 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: 17701932
• Report Number: 2026095-2023-00097
• Device Sequence Number: 6632013
• Product Code: MEB
• UDI-Device Identifier: 10680651135688
• UDI-Public: 10680651135688
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/29/2025
• Device Model Number: C270050
• Device Catalogue Number: N/A
• Device Lot Number: 30225018
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 64 KG