CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
Recall
- Recall Number
- Z-0595-2024
- Event Number
- 93462
- Firm
- Maquet Medical Systems USA
- FEI Number
- 3008355164
- Product Code
- DTQ
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- November 14, 2023
- Posted
- September 30, 2024
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780; 701048012
CARDIOHELP-i System was not properly tested to measure leakage current
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 [email protected] 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
Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Macao, Maldives, Martinique, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom,Vietnam, Yemen
1594 units