MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES, 270 ML, 10 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number	C270100
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30085008 was reviewed and the product was produced according to product specifications.All information reasonably known as of 14 jul 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the patient was receiving 12 hour infusions of fortum ceftazidime 3gr /142ml nacl twice a day for 11 days.During this reported event, the patient received the infused dose in 1 hour instead of 12 hours.There were no side effects or injury reported.Per additional information received 7 jul 2021: fill volume: 150ml.Flow rate: 10ml/hr.Procedure: infusion with homepump 12 hours two times a day ¿ ceftazidime 3g with 142ml nacl.Catheter placement: arm.Infusion start time: 8am.Infusion stop time: 9am (should have lasted until 8pm).

• Brand Name: HOMEPUMP C-SERIES, 270 ML, 10 ML/HR (CONTAINS DEHP)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12176324
• Report Number: 2026095-2021-00077
• Device Sequence Number: 19240360
• Product Code: MEB
• UDI-Device Identifier: 00193494135690
• UDI-Public: 00193494135690
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 02/10/2023
• Device Model Number: C270100
• Device Catalogue Number: N/A
• Device Lot Number: 30085008
• 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: 06/29/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR