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 Code	Hot Flashes/Flushes (2153)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Avanos medical received a single report that referenced seven different incidences, which were associated with separate units, involving seven different events.This is the first of seven reports.Refer to 2026095-2023-00071 for the second event.Refer to 2026095-2023-00072 for the third event.Refer to 2026095-2023-00073 for the fourth event.Refer to 2026095-2023-00074 for the fifth event.Refer to 2026095-2023-00075 for the sixth event.Refer to 2026095-2023-00076 for the seventh event.Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown, infustion start time: (b)(6) 2023 11:07am, infection stop time: (b)(6) 2023 08:30am.It was reported the pump infused faster than the 46-hour timepoint, and when the pump runs fast the patient experiences flushing as a side effect.There was no reported injury or medical intervention.
Additional Manufacturer Narrative
The actual device is reported to be available but has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 11-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.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30234039, 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 22-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.
Additional Manufacturer Narrative
The device was evaluated.The evaluation summary noted the sample did not show any infusion on the glass orifice portion of the pump while verifying the infusion in different locations of the tubing.After rehabilitating the tubing by cutting multiple areas to identify the location of occlusion/ blockage, the area of occlusion/ clogging was in the flow restrictor (glass orifice).An unknown substance was unable to dissolve.The filter was also exhibited to leak.Reported "fast flow" was not confirmed.Root cause could not be determined.All information reasonably known as of 22-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.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.All information reasonably known as of 11-oct-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: 17302955
• Report Number: 2026095-2023-00070
• Device Sequence Number: 20504346
• Product Code: MEB
• UDI-Device Identifier: 00193494135683
• UDI-Public: 00193494135683
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/22/2023

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: Lay User/Patient
• Device Expiration Date: 06/24/2025
• Device Model Number: C270050
• Device Catalogue Number: N/A
• Device Lot Number: 30234039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 09/01/2023; 09/18/2023; 12/06/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 09/22/2023; 10/12/2023; 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5FU.
• Patient Sex: Male