MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES, 300 ML, 6 ML/HR (WITH DEHP); ELASTOMERIC LFR

Model Number C300060

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Pain (1994)

Event Date 02/16/2024

Event Type  malfunction  

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 27-mar-2024 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 comp (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 : devie not returned.

Event Description

Fill volume: unknown, flow rate: unknown , procedure: unknown , cathplace: unknown, start time: on (b)(6) 2024 at 18:22, stop time: on (b)(6) 2024 at 19:00.It was reported "the infuser lasted a total of 48.5 hours, when in theory according to the technical product information it should have lasted 60 hours." the patient reported pain and required oral and venous pain management.There was no reported injury.

• Brand Name: HOMEPUMP C-SERIES, 300 ML, 6 ML/HR (WITH DEHP)
• Type of Device: 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. 22116 ; MX 22116
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18989929
• MDR Text Key: 338746356
• Report Number: 2026095-2024-00015
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494135706
• UDI-Public: 00193494135706
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C300060
• Device Catalogue Number: N/A
• Device Lot Number: 30209735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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