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

Model Number C270020

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Nausea (1970); Unspecified Gastrointestinal Problem (4491)

Event Date 04/10/2022

Event Type  Injury  

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 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.

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 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.

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 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.

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
• 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: 14332544
• MDR Text Key: 293354396
• Report Number: 2026095-2022-00050
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494135669
• UDI-Public: 00193494135669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 05/08/2022
• Supplement Dates Manufacturer Received: 05/09/2022; 05/09/2022; 02/02/2023
• Supplement Dates FDA Received: 05/23/2022; 05/31/2022; 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5 FLUOROURACIL.; MITOMYCIN/5FU 96 HOUR INFUSION.; MITOMYCIN/5FU 96 HOUR INFUSION.
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 60 KG