MAUDE Adverse Event Report: AVANOS MEDICAL INC. HOMEPUMP C-SERIES ELASTOMERIC PUMP, 100 ML, 2 ML/HR, (DEHP-FREE); NON-DEHP PUMP - LFR

Model Number C100020-S

Device Problem Infusion or Flow Problem (2964)

Patient Problems Fatigue (1849); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 24 sep 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).Device not returned.

Event Description

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 2026095-2020-00121 for the first report.Fill volume: 95ml; flow rate: 2ml/hr; procedure: chemotherapy delivery; cathplace: unknown; infusion start time: unknown; infusion stop time: unknown.It was reported that the patient had a pump that infused "30% faster than it should have." the patient had extreme fatigue, lack of appetite, and sores in his mouth.Patient's current condition was reported as "stable but still has mouth sores." pump was carried in bag.Lot number is unavailable.

• Brand Name: HOMEPUMP C-SERIES ELASTOMERIC PUMP, 100 ML, 2 ML/HR, (DEHP-FREE)
• Type of Device: NON-DEHP PUMP - 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10586647
• MDR Text Key: 209013870
• Report Number: 2026095-2020-00122
• Device Sequence Number: 1
• Product Code: MEB
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: C100020-S
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 66