ABIOMED

Circulatory Support Systems

Impella RP IMP-370 Supplement to Instructions for Use v2 Feb 2021

Supplement to Instructions for Use

3 Pages

MRC-001 Rev A... Supplement: Temporary modification to indications for use for extracorporeal support devices  OXY-1 System  RELEASED  Background On April 6, 2020 the United States Food and Drug Administration (FDA) published the following guidance: “Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices during the Coronavirus Disease 2019 (COVID-19) Pubic Health Emergency...  Under this guidance, the FDA is allowing temporary limited modifications to the indications of certain FDA-cleared or FDA-approved cardiopulmonary devices without prior submission of premarket notification... hese modifications are allowed, in light of the public health emergency, when they do not create an undue risk... his indication modification is in effect for the duration of the public health emergency related to COVID-19, as declared by the Department of Health and Human Services (HHS)... Indications for use In accordance with the FDA guidance, the devices listed below have a modified indication for use during the COVID-19 public health emergency... his indication modification has not been cleared or approved by the FDA, but shall apply temporarily to the device models listed in this supplement:  The device can be used for longer than 6 hours in an extracorporeal membrane oxygenation (ECMO) circuit to treat patients who are experiencing acute respiratory or acute cardiopulmonary failure... The table below shows the system part numbers, device descriptions, and FDA-cleared indications for use for the various cardiopulmonary devices granted the above modified indication... System Part Numbers* 001-0500-100  Device Description FDA-Cleared Indications for Use  OXY-1 Console with accessories: • Pump Driver • E-Drive • E-Drive pole mount • Pole Mount  The Oxy-1 System is intended to be used for extracorporeal circulation cardiopulmonary bypass... he Oxy-1 System pumps, oxygenates and removes carbon dioxide from blood within the indicated flow rates for use up to six hours in duration... Page 1 of 3   MRC-001 Rev A... System Part Numbers* 001-0400-100  Device Description FDA-Cleared Indications for Use  OXY-1 PLU Disposable • Pump Lung Unit • Priming Kit • Cable Guard • Condensate Tray • Console Intake Filter  The Oxy-1 System is intended to be used for extracorporeal circulation cardiopulmonary bypass... he Oxy-1 System pumps, oxygenates and removes carbon dioxide from blood within the indicated flow rates for use up to six hours in duration... Device performance There are no changes to device performance as described in the instructions for use for these devices... Durability testing Abiomed has successfully conducted the following reliability testing: • Blood Pump Reliability for 30 days • Pump Driver Motor Reliability for 1 year • The OXY-1 System durable component demonstrated 36-month service life  Abiomed has reviewed vendor data and concluded the following reliability: • The OXY-1 System’s internal Oxygen Concentrator has a service life of 3 years  Animal and Clinical testing Abiomed has successfully conducted bio-compatibility testing to required support patient contact for ≤24hr... Potential risks There are risks and adverse events related to all extracorporeal life support (ECLS) procedures and anticoagulation, including: heart, vessel, or lung damage, hypoxia or hypercarbia due to inadequate gas exchange, anemia, infection, hemorrhage, liver or kidney failure, stroke, and death... See the device IFU for device-specific risks and potential adverse effects... Clinical signs or observations that suggest device changeout is necessary The blood pump should be evaluated for changeout if the clinician determines during the extracorporeal procedure that adequate patient support is not being achieved... xamples of device performance-related indications that a changeout is needed may include inadvertent trauma or evidence of cracking, an audible rattling noise caused by air bubbles in the pump head, or severe hemolysis or thrombus formation If a changeout is deemed necessary, obtain a replacement device before discontinuing circulation Page 2 of 3
File Type: PDF
File Size: 187 KB
File Name: Impella RP IMP-370 Supplement to Instructions for Use v2 Feb 2021.pdf

By clicking Download you are confirming this is the correct document for your purposes
and that you agree to our Terms & Conditions