Supply Issues Getinge Maquet Structural Heart Products (ICN 1943)

• The supplier Getinge Maquet has informed us that they have now issued a Field Safety Notice for all of their Intra-Aortic Balloon (IAB)
• Please see ICN 2180 for full details of the Field Safety Notice.
• As a result of the publication of the Field Safety Notice, Getinge Maquet has removed the global shipment hold that had previously been in place and a limited amount of stock is being supplied into the UK and Ireland, as a result of the national stock take, NHS Supply Chain and Getinge Maquet have been working together to allocate stock accordingly.
• Further stock will be available in the coming weeks, but the expectation is that supply will continue to be limited for a number of weeks while corrective manufacturing actions are put in place.

• The supplier Getinge Maquet has informed us of an update to the supply issue with its Intra-Aortic Balloon (IAB) catheters and is currently stopping any shipments of the products.
• Management of the IAB catheter shipment hold and the subsequent supply disruption has been escalated and the response is being co-ordinated and directed from a national level.
• A national stock take is required to understand the level of stock across the country and will subsequently help with the distribution of stock when it becomes available. The request for the stock take has been cascaded via the Single Point of Contact team at the National Operations Centre within NHS England.
• Discussions are ongoing between the Medical Device Regulator and Getinge.
• The following clinical professional bodies are involved in national conversations regarding this supply disruption: British Cardiovascular Intervention Society (BCIS), Society for Cardiothoracic Surgery (SCTS) and Society of Clinical Perfusion Scientists (SCPS).
• BCIS, SCTS and SCPS have made a joint statement on the ongoing ship hold and subsequent supply issue. See our Useful Links section for further information.

• In addition to the update earlier, the supplier Getinge Maquet has informed us that 10 of the previously affected product codes, within the Intra-Aortic Balloon range have now been placed on a global shipment hold.
• The ship hold has been put in place to allow Getinge Maquet to further investigate potential quality concerns related to the insertion kit used with these Intra-Aortic Balloons.
• The product codes affected by this ship hold are as follows.
  • FKL797 – Balloon – Intra-Aortic (IC)
  • FKL798 – Balloon – Intra-Aortic (IC)
  • FKD602 – Balloon – Intra-Aortic (IC)
  • FVI3584 – Balloon – Intra-Aortic (IC)
  • FVI4214 – Balloon – Intra-Aortic (IC)
  • FRE3106 – Balloon – Intra-Aortic (IC)
  • FRE3107 – Balloon – Intra-Aortic (IC)
  • FRE3108 – Balloon – Intra-Aortic (IC)
  • FXE001 – Balloon – Intra-Aortic (IC)
  • FVI3585 – Balloon – Intra-Aortic (IC).
• See our Downloads ▼ section to access the product listing and customer letter for further information on the affected product codes and potential alternatives.
• Although we do not currently have a resolution date for the supply issue, we will update the ICN as soon as we have further information.

• The supplier Getinge Maquet has informed us that this supply issue is ongoing.
• The supplier CE certification has been suspended for some of their product codes within the Perfusion range.
• The CE certification has been suspended by DEKRA due to changes in packaging design that resolved a previous issue around breaches in the sterility of the devices.
• A further three product codes are now affected.
• The three additional product codes affected do not demonstrate compliance with the essential requirements according to the Medical Device Directive and applicable standards:
  • FXA182 – Adult Oxygenators
  • FXA405 – Adult Oxygenators
  • FXA538 – Adult Oxygenators.
• The remaining 10 affected product codes remain subject to intermittent supply.
• One product code, which is directly supplied from the supplier remains suspended:
  • Cardiosave IABP MPC: D998-00-0800-52.
• There are 13 product codes affected in total.
• There are currently no alternatives available for these product codes due to their compatibility with the capital equipment however, we are in the process of sourcing these.
• See our Downloads ▼ section to access the customer letter for further information.
• Although we do not currently have a resolution date for the supply issue, we will update the ICN as soon as we have further information.

• The supplier Getinge Maquet has informed us the supply issue with its Structural Heart products is ongoing.
• One of the previously affected product codes, which is directly supplied from the supplier has had its CE marking suspended for up to three months:
  • Cardiosave IABP MPC: D998-00-0800-52.
• This is effective immediately, Getinge cannot sell Cardiosave to any country requiring a CE mark.
• 10 of the affected product codes are still subject to intermittent supply.
• Potential indirect alternative products are available to order through our online catalogue.
• Please note there are no potential alternatives available to order through our online catalogue for three of the affected product codes, however, we are in the process of sourcing these.
  • FVI3584, FRE3106, and FRE3107.
• See our Downloads ▼ section to access the product listing and customer letter for further information on the affected product codes and potential alternatives.
• Although we do not currently have a resolution date for the supply issue, we will update the ICN as soon as we have further information.

Change:

• The supplier Getinge Maquet has informed us of a supply issue with its Structural Heart products.
• There are 11 product codes affected.
• The supply issue is due to a longer lead time with manufacturing due to plastic shortages, and battery components products.
• The current lead time is 14 weeks, where normally it is six to eight weeks.

Impact:          

• The affected product codes are subject to intermittent supply.
• However, products are still being manufactured and the risk of shortages are minimal.
• Due to year end capital spending, customers are advised to place orders ahead of April 2023, the end of the financial year.
• Potential indirect alternative products are available to order through our online catalogue:
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The supply issue is anticipated to be resolved within three to six months.
• We will update the ICN when we have further information.

Next Steps:              

• Customers are advised to log into our website to view the potential indirect alternative products.
• If you have any further questions, please contact your local NHS Supply Chain Customer Services Advisor.

Please note that due to the clinical nature of these alternative products we advise you to consult your own clinical experts to ensure suitability for your organisation’s use of these products.