Dear Risk Manager,
Maquet Cardiopulmonary GmbH (MCP)/Getinge is initiating a voluntary Medical Device Correction for the HLS Set Advanced (disposable in the CARDIOHELP System) due to insufficient evidence of packaging sterility.
The HLS Set Advanced is part of the CARDIOHELP System, which is intended to provide circulatory and/or pulmonary support (for periods up to six hours).
MCP/Getinge has not received any reports of complaints or adverse events due to this issue.
The previously issued Urgent Medical Device Removals (FDA Reference Numbers: Z-0632-2021 & Z-0633-2021, November 20, 2020 letter and Z-1764-2022 through Z-1767-2022, July 22, 2022 letter) are separate from and not affected by this Urgent Medical Device Correction and the already defined actions remain in effect.
Through communications with one of the Regulatory Authorities, a gap was identified in packaging validation testing for HLS Set Advanced that may compromise sterility. This testing was performed in order to validate changes made in the packing design in order to prevent damage to the tray and pouches.
Because of this nonconformance, MCP/Getinge voluntarily established a quality shipping-hold on December 8th, 2022.
Potential packaging issues were previously identified during internal validation testing. Issue 1, damage to the tray and Issue 2, damage to the sterile accessory pouches, which may not be visible to the naked eye. Corrective actions were implemented in September 2021 for each issue consisting of an assembly process change and introducing 100% inspection.
The packaging tests in question were immediately and successfully repeated on HLS Set Advanced from Getinge’s inventory (product that is shipped to customers). This was the basis for resuming product shipments in late December. This testing confirmed effectiveness of the corrective actions. However it did not follow internal MCP/Getinge protocol and will be repeated in April 2023 according to protocol. Based on the test results under market configuration, we are confident to confirm the conformity of the affected products.
Issue 1 – Crack on the outside of the sterile tray introduced during the packaging assembly process.
Risk to Health:
Exposure to a non-sterile or potentially non-sterile medical device, or a delay in the procedure, may result in following immediate and/or long-range health consequences:
Symptoms may include but are not limited to localized and/or systemic inflammatory reaction, pyrogenic reaction (fever), stimulation of humoral immune response (SIRS), activation of coagulation and complement cascade and/or release of inflammatory molecules, e.g. cytokines.
Actions to be taken by the Customer:
Our records indicate that you have received the HLS Set Advanced having the product codes that are potentially affected by this Medical Device Correction.
- Please examine your inventory immediately to determine if you have any of the affected HLS Set Advanced with the product codes listed on page 1 of this notice and acknowledge that you have received this notification by following the instructions below.
- Should you continue to use affected product, the potential risk of exposure that may lead to immediate and/ or long range health consequences is listed in Risk to Health above If an affected device is already in use, please use according to normal practices. Monitor the patient for signs and symptoms as listed above under Risk to Health and, if detected, treat according to clinical protocols.
- Please note that all available and newly produced devices are affected by this Urgent Medical Device Recall Should you need to continue to use and/ or purchase this product for use you will continue to receive product affected by this potential issue until validation testing is concluded.
There are two potential options you may take for affected inventory
Option 1 (stop use / return product):
- Should you have any unused and unexpired affected product, you are eligible to return all affected product for credit. Please contact Getinge Customer Service at (888) 9GETUSA / (888) 943-8872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization (RMA) and shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided, arrange for pickup with the designated delivery service provider.
- Please also enter the affected lot numbers, quantity and RMA number provided by Customer Service in the spaces provided on the Medical Device Correction - Response Form on Page 5 of this letter, if you are returning products to Maquet/Getinge.
- If you do not have alternative product available for use, you may continue use of this product, however please review the information provided under Risk to Health in this letter. Monitor the patient for signs and symptoms as listed above under Risk to Health and, if detected, treat according to clinical
- Perform a visual inspection of the primary packaging, check for visible stress marks or damages in the packaging. In case of visible stress marks in the packaging, do not use the product and return for replacement or credit note.
- Please note that there is a possibility that packaging defects may not be detectable by the naked eye.
- Continue to use in accordance with Instructions for Use G-660 Revision 4, Section 6.1 Warning – Damage to the device or packaging.
- The use of non-sterile or defective devices can result in infection of the patient, user and third parties. See Section 4.1 (Basic Safety Instructions) in the Instructions for Use G-660 Revision 4.
- Only use the device if it is sterile.
- Do not use the device if it or the sterile packaging is damaged.
- Observe the use-by date on the packaging.
- Always observe strict asepsis when handling.
- Stacking the product in its primary packaging can damage the sterile barrier.
- Do not stack sets on top of each other in their primary packaging.
- Follow all other instructions on the packaging and the instructions for use
- Please report any adverse events, g. infections potentially related to the affected products to Getinge Customer Service at (888) 9GETUSA / (888) 943-8872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time and to FDA as listed below.
- Please forward this information to all current and potential HLS Set Advanced users within your hospital/facility. This may include teams in the ICU, CT Surgery, Cath Lab, Patient Transport, and/or others.
- If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.
- Whether you have affected product or not, please complete and sign the attached MEDICAL DEVICE CORRECTION– RESPONSE FORM (Page 5) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to US@getinge.com or by faxing the form to (877) 665-2398.
Actions by Getinge:
MCP/Getinge is working with all possible urgency to complete the testing on test samples treated according to internal protocol. Once these results are available, we will reassess if further measures are needed to ensure patient safety. As previously discussed, Corrective Action was implemented in September 2021 and testing on market configuration samples was completed in December 2022.
Please note that you will continue to receive product affected by this potential issue until which time this activity has concluded.
This voluntary Medical Device Correction only affects the products listed on page 1; no other products are affected by this voluntary Medical Device Correction.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program using one of the following methods:
- Online: accessdata.fda.gov/scripts/medwatch/
- Regular Mail: Download form fda.gov/MedWatch/getforms.htm or call 1-800-332- 1088 to request a reporting form, then complete and return to the address on the pre- addressed form
- Fax: 1-800-FDA-0178
We apologize for any inconvenience this voluntary Medical Device Correction may cause. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 9GETUSA / (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
This recall is being made with the knowledge of the U.S. Food and Drug Administration.
Allison Jean Kaplan
Specialist II, Regulatory Affairs and Field Action Compliance