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

Model Number	C300060
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Nausea (1970); Swelling (2091); Tingling (2171)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot 30039131 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 07 dec 2020 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).
Event or Problem Description
Fill volume: 298 ml, flow rate: 6 ml/hr, procedure: chemotherapy, cathplace: unknown, infusion start time: unknown, infusion stop time: unknown.Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving the same patient.This is the second of two reports.Refer to 2026095-2020-00180 for the first report.It was reported that the pump infused too quickly.Patient experienced nausea, swelling of tongue, and tingling of extremities during infusion.Infusion was completed when pharmacy was made aware.Medrol dose pack prescribed for treatment.Patient currently in "stable" condition and as received additional infusions.Additional information received 23-nov-2020 indicated the pharmacy verified with the patient that she is caring for the pump appropriately.

• Brand Name: HOMEPUMP C-SERIES, 300 ML, 6 ML/HR (CONTAINS DEHP)
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10970726
• Report Number: 2026095-2020-00181
• Device Sequence Number: 4282980
• Product Code: MEB
• UDI-Device Identifier: 00193494135706
• UDI-Public: 00193494135706
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K052117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 08/17/2022
• Device Model Number: C300060
• Device Catalogue Number: N/A
• Device Lot Number: 30039131
• 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: 11/18/2020
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Weight: 47