Dear Healthcare Providers,
We are writing to inform you of an important safety notice regarding Terumo Platelet Additive Solution+ (T-PAS+). Please carefully review the following information:
Device Details:
- Device Type: Terumo Platelet Additive Solution+ (T-PAS+)
- Commercial Name: Terumo Platelet Additive Solution+ (T-PAS+)
- Primary Clinical Purpose: The T-PAS+ solution is a platelet additive solution intended to partially replace plasma in the preparation and storage of a buffy coat-derived platelet concentrate or apheresis platelet unit.
- Device Model/Catalogue/Part Numbers: 40853, 40855, 40856
- Affected Serial or Lot Number Range:
- C/N 40853 - 23052020, 23052021
- C/N 40855 - 23054013, 23054014
- C/N 40856 - 23055009
Reason for Field Safety Corrective Action (FSCA):
1. Product Problem Description:
The T-PAS+ lots listed above may contain oil residue on the luer connectors used to mix additive solution with collected platelet products, including the frangible connector that is in direct contact with the additive solution.
2. Hazard and Probability:
There is a possibility that this oil residue may transfer into the fluid pathway of the additive solution and into the final collected product. This residue has been identified as Renolin B 15 VG 46, which is not intended for use in medical applications.
Terumo Blood and Cell Technologies has received no reports of adverse events or injuries related to the presence of oil residue on T-PAS+ products.
3. Predicted Risk:
There is potential for adverse consequence due to pulmonary oil microembolism (POME) in the population at greatest risk in the event the residue transfers into a platelet product and is subsequently transfused. The population at greatest risk is defined as neonates, pediatrics, critically ill patients, and those with impaired lung function. In the general population, this potential degree of oil residue is not likely to cause an adverse health consequence.
We strongly advise healthcare providers to take immediate action to identify and quarantine affected lots. For further guidance on how to proceed, please contact the terumo team at https://www.terumobct.com/contact-us?showAddresses=true
Your patients' safety is our top priority, and we appreciate your prompt attention to this matter.
