MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP); ELASTOMERIC LFR

Model Number C270020

Device Problem Infusion or Flow Problem (2964)

Patient Problem Inflammation (1932)

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 101356604, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 01-may-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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: 201 ml, flow rate: 2ml/hr, procedure: unknown, cathplace: picc line, start date: (b)(6) 2019 at 1530, stop date: (b)(6) 2019.It was reported the pump was filled with 20/ml normal saline and 5 fu to deliver over 4-days, but device emptied in about 2-days per the patient.The clinician decreased chemotherapy dosing for the subsequent cycles.There was no reported injury.

Manufacturer Narrative

A review of the device history record is not possible as the correct lot number was provided.All information reasonably known as of 11-jul-2019 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)(6).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, 270 ML, 2 ML/HR (CONTAINS DEHP)
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8579436
• MDR Text Key: 144017223
• Report Number: 2026095-2019-00074
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651135668
• UDI-Public: 30680651135668
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: C270020
• Device Catalogue Number: 101356600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 07/12/2019
• Patient Sequence Number: 1
• Treatment: 20/ML NS AND 5 FU; 20/ML NS AND 5 FU
• Patient Age: 70 YR
• Patient Weight: 41