CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through t

FDA device recall Z-0595-2024 · posted 2024-09-30 · Open, Classified

Recall details

Recalling firm

Maquet Medical Systems USA

Reason for recall

CARDIOHELP-i System was not properly tested to measure leakage current

Action taken

Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device Correction Letter to U.S, consignees November 14, 2023 via FedEx. Letter states reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have any affected CARDIOHELP-i in your inventory. " Whether or not your facility has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM (Page 4) to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to Cardiopulmonary-cardiohelpleakage2023.cp@getinge.com or by faxing the form to 1-800-530-6084. " If you report having any affected CARDIOHELP-i devices, a local Getinge representative will contact you to arrange a system check of the device to ensure that leakage current is within specifications. " Affected CARDIOHELP-i devices are not requested to be returned and can be used as usual. " Please forward this information to all current and potential CARDIOHELP-i users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. Type of Action by Getinge: Getinge has identified the issue to be related to a supplier using an incorrect drawing to produce a tool used to measure leakage current of the CARDIOHELP-i. This issue has been corrected by the supplier. MCP/Getinge will contact you to arrange for a MCP/Getinge service technician to perform a system check of any affected device you report to confirm leakage current is within specifications (IEC 62353). If a system fails the performed test, the MCP/Getinge service technician will replace the system s sensor panel for you. MCP/Getinge service may have already performed the required system check of your device during a past preventative maintenance. MCP/Getinge will check service records to confirm. MCP

Root cause

Process design

Status

Open, Classified

Product code

DTQ

Quantity affected

1594 units

Distribution

Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominic

Date initiated

2023-11-14

Date posted

2024-09-30

Location

Wayne, NJ

Related 510(k) clearances