MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES*, 270 ML, 5 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number C270050

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Abdominal Pain (1685); Fever (1858); Tachycardia (2095); Hyponatremia (4494)

Event Date 02/10/2022

Event Type  Injury  

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 not possible as no lot number was provided.All information reasonably known as of 03-mar-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.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 Description

Fill volume: unknown.Flow rate: unknown.Procedure: chemotherapy treatment.Cathplace: unknown.Date of procedure: (b)(6) 2022.It was reported the pump infused in over 24-hours instead of 46-hours.The patient had a temperature of 101.9f but there was no reported injury.Additional information received 01-mar-2022 stated the patient was admitted to the hospital on (b)(6) 2022 with an on-q pump that had infused in 24-hours instead of 48-hours.The patient was admitted due to 5fu toxicity.The patient received treatment with uridine acetate, 10 mg, the pharmacist was unsure of the frequency of treatment.The patient received a total of 20 doses over the 5-day period.The patient recovered and was discharged home on (b)(6) with ongoing symptoms of tachycardia, abdominal pain, and hyponatremia (low sodium).All symptoms were manageable from home.

Manufacturer Narrative

The device history record for the reported lot number, 20074842, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual sample device was received empty.The device was evaluated and the reported fast flow was not replicated during the sample evaluation.Limited information was provided, therefore, it is unknown if the user or facility conditions could contribute to the reported fast flow during the use of the device.The investigation determined that the returned device functioned as intended during the sample evaluation, no defect was found; therefore, complaint is not confirmed.Root cause could not be determined.All information reasonably known as of 15-apr-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, 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.

• 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: 13663808
• MDR Text Key: 286590643
• Report Number: 2026095-2022-00010
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494135683
• UDI-Public: 00193494135683
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

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 Expiration Date: 02/28/2024
• Device Model Number: C270050
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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: 5FU
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male