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

Model Number C270020

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Dyspnea (1816); Nausea (1970); Rash (2033)

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The device history record for lot 0203007611 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 jun 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 halyard health complaint database and identified as complaint (b)(4).

Event Description

Fill volume: unknown; flow rate: unknown; procedure: unknown; cathplace: unknown; infusion start time: unknown; infusion stop time: unknown.It was reported that the device "with 5-day infusion of 5fu [fluorouracil] and ns [normal saline] infused faster than desired." additional information received on (b)(6) 2019 indicated the patient experienced nausea, shortness of breath, and rash that appeared over torso and under port dressing after pump connection.Intervention consisted of "iv emend, ct [computed tomography] to r/o [rule out] pe [pulmonary embolism], o2 sat [oxygen saturation] monitoring in clinic.".

Manufacturer Narrative

The actual complaint product was returned for evaluation.The pump was received empty and was refilled with 0.9% of saline to the nominal value of 270ml.A fast flow was not observed on the pump.The flow accuracy test, pressure pot testing, and flow rate were within specification.No root cause was identified.All information reasonably known as of 13 sep 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 halyard health 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 - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 8665929
• MDR Text Key: 151048898
• Report Number: 2026095-2019-00107
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 10680651135664
• UDI-Public: 10680651135664
• Combination Product (y/n): N
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/15/2019

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: 11/27/2020
• Device Model Number: C270020
• Device Catalogue Number: 101356600
• Device Lot Number: 0203007611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/15/2019
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL; NORMAL SALINE
• Patient Age: 48 YR
• Patient Weight: 76