MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES; ELASTOMERIC LFR

Model Number	C270020
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Codes	Nausea (1970); Unspecified Gastrointestinal Problem (4491)
Date of Event	04/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.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).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 or Problem Description
Fill volume: 192 ml, flow rate: 2 ml/hr, procedure: chemotherapy, cathplace: unknown, infusion start time: (b)(6) 2022, infusion stop time: (b)(6) 2022.It was reported that the c series pump infused one day early; the intended length of infusion was to be four days.The patient reportedly experienced gastrointestinal (gi) distress as a result of the fast flow incident.No medical intervention required as a result of the reported gi distress.
Additional Manufacturer Narrative
Additional information: b3 (medwatch/ fda user facility report #(b)(4).The device was not returned for evaluation, however, per the customer provided information, the pump was filled up to 192 ml for a 4 days infusion, however, per the instructions for use for the device, this volume is less than the recommended fill volume (201 ml) for a 96 hour infusion.According to the "cautions" section of the ifu: "flow rates may vary due to: fill volume - filling the pump less than labeled (nominal) fill volume results in faster flow rate." therefore, it is possible that the fill volume is a contributor to the reported incident.However, without functionally evaluating the sample is not possible to confirm the incident as reported.All information reasonably known as of 18 may 2022 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 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 or Problem Description
Additional information received 09may2022 from medwatch/fda user facility report #(b)(4), reported the patient was nauseated and required intravenous fluids (iv) in the emergency room (er).The patient's current condition was not reported.
Additional Manufacturer Narrative
Additional information: b3 (medwatch/ fda user facility report #(b)(4).The device was not returned for evaluation, however, per the customer provided information, the pump was filled up to 192 ml for a 4 days infusion, however, per the instructions for use for the device, this volume is less than the recommended fill volume (201 ml) for a 96 hour infusion.According to the "cautions" section of the ifu: "flow rates may vary due to: fill volume - filling the pump less than labeled (nominal) fill volume results in faster flow rate." therefore, it is possible that the fill volume is a contributor to the reported incident.However, without functionally evaluating the sample is not possible to confirm the incident as reported.All information reasonably known as of 18 may 2022 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 complaint database and identified as complaint comp-ghc-22-01216.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 or Problem Description
Additional information received 09may2022 from medwatch/fda user facility report #(b)(4), reported the patient was nauseated and required intravenous fluids (iv) in the emergency room (er).The patient's current condition was not reported.
Additional Manufacturer Narrative
All information reasonably known as of 06 feb 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 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
• 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: 14332544
• Report Number: 2026095-2022-00050
• Device Sequence Number: 12328617
• Product Code: MEB
• UDI-Device Identifier: 00193494135669
• UDI-Public: 00193494135669
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/06/2023

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 Model Number: C270020
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 05/09/2022; 05/09/2022; 02/02/2023
• Initial Report FDA Received Date: 05/08/2022
• Supplement Report FDA Received Date: 05/23/2022; 05/31/2022; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 5 FLUOROURACIL.; MITOMYCIN/5FU 96 HOUR INFUSION.; MITOMYCIN/5FU 96 HOUR INFUSION.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 60 KG