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

Model Number C270020-10

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Chest Pain (1776); Tingling (2171)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0203047983 was reviewed and the product was produced according to product specifications.All information reasonably known as of 29 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 halyard health complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 211 ml; flow rate: 2ml/hr; procedure: chemo treatment; cathplace: unknown; infusion start time: 1502 on (b)(6) 2019 infusion stop time: unknown.It was reported that the pump was placed (b)(6) 2019 at 3:02pm.On (b)(6) 2019 at 10:50am the patient returned for f/u [follow-up] related to another therapy and nurse noted that pump was empty; it was scheduled to complete on (b)(6) 2019 at 4:00pm.Same day, (b)(6) 2019, patient had f/u with cardiologist for c/o [complaint of] chest discomfort.Notes from cardiologist report "pt [patient] reported since (b)(6) 2019 experienced intermittent chest discomfort.Experienced sharp chest discomfort the night of (b)(6) 2019, relieved with motrin.On the morning of (b)(6)2019 further episodes of chest discomfort which was somewhat positional, relieved by sitting up straight, also at this time experienced tingling in arms.Evaluated on (b)(6) 2019, no current chest discomfort at time of evaluation by cardiologist.Pt.Reports perhaps mild shortness of breath, no diaphoresis or other cardiac complaints.He does not have known ischemic heart disease, progressive angina, heart failure symptomatology or arrythmia hx [history].Ekg [electrocardiogram] shows st elevation concerning for possible mi [myocardial infarction].Sinus rhythm with 1st degree av [atrioventricular] block with early polarization; consider pericarditis." additional information received on (b)(6) 2019 indicated the pump was filled on (b)(6) 2019 with normal saline using repeater then the drug fluorouracil via syringe technique for medication.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The investigation is in progress.All information reasonably known as of (b)(6) 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.

Manufacturer Narrative

The actual complaint product was returned for evaluation.The pump was received empty.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 100ml.Infusion was verified on the 2ml flow rate at the distal luer.A fast flow was not observed for the pump.During the flow accuracy test, the pump was below specifications.During pressure pot testing, the flow rate result met specifications with a +/- 15% tolerance.Root cause could not be determined.All information reasonably known as of (b)(6) 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: 8653565
• MDR Text Key: 151268707
• Report Number: 2026095-2019-00095
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

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: Lay User/Patient
• Device Expiration Date: 01/24/2021
• Device Model Number: C270020-10
• Device Catalogue Number: 103488200
• Device Lot Number: 0203047983
• 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: 05/10/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 05/29/2019; 07/10/2019
• Supplement Dates FDA Received: 06/19/2019; 07/18/2019
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL; NORMAL SALINE
• Patient Age: 63 YR
• Patient Weight: 98