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 Atrial Fibrillation (1729); High Blood Pressure/ Hypertension (1908)

Event Date 10/06/2021

Event Type  Injury  

Event Description

Fill volume: 241 ml, flow rate: 5ml/hr, procedure: chemotherapy infusion, cathplace: unknown, date of procedure: (b)(6) 2021, pump start date: (b)(6) 2021 at 1401, pump completed date: (b)(6) 2021 at 1401.It was reported the patient went for a pump disconnection reporting elevated blood pressure (bp) and heart rate and was sent to emergency department (ed).The patient noticed that the pump had completely emptied within 12-hours.This was the patient's 11th chemotherapy cycle.Additional information received 04-nov-2021 noted the following clinical interpretations.The patient went to the ed on (b)(6) 2021.While in the ed the pump was connected.The patient received a diltiazem intravenous (iv) drip and given a dose of metoprolol.The patient was admitted to hospital that day and discharged on (b)(6) 2021.While in the hospital the patient was switched from a diltiazem iv drip to metoprolol 25mg, administered twice a day bid for atrial fibrillation for rapid ventricular response (rvr).Initially the p[ump was prescribed to infuse for 46-hours at 2400mg/m2 continuously over at 5ml/hr every 2-weeks.".

Manufacturer Narrative

The device history record for the reported lot number, 20055546, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 22-nov-2021 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).

• Brand Name: HOMEPUMP C-SERIES, 270 ML, 5 ML/HR (CONTAINS DEHP)
• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12865197
• MDR Text Key: 285617450
• Report Number: 2026095-2021-00107
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2023
• Device Model Number: C270050
• Device Catalogue Number: N/A
• Device Lot Number: 20055546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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: FLUOROURACIL 90 ML NS 151ML
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 78 KG