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

Model Number C270050

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Diaphoresis (2452)

Event Date 03/17/2023

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 16-may-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.

Event Description

Flow rate: 5 ml/hr.Procedure: chempotherpy.It was reported the device infused sooner than expected.The patient was received on the unit for removal of the fluoruracil infuser.The device was installed on (b)(6) 2023.The patient reports the medication infusion ended on (b)(6) 2023.The patient reported sweating a lot.The patient asked about the advance of the end of medication cycle, "since he is in the 04 cycle of the protocol and in the previous ones there was no such event." there was no reported injury.

Manufacturer Narrative

The device history record for the reported lot number, 30179780, 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 19-jul-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)
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16949731
• MDR Text Key: 315465006
• Report Number: 2026095-2023-00061
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494135683
• UDI-Public: 00193494135683
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

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
• Device Operator: Health Professional
• Device Model Number: C270050
• Device Catalogue Number: N/A
• Device Lot Number: 30179780
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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: FLUORURACIL INFUSER
• Patient Age: 62 YR
• Patient Sex: Male