Separator, Automated, Blood Cell And Plasma, Therapeutic
FDA adverse event reports and recall history for separator, automated, blood cell and plasma, therapeutic (product code LKN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,753
- Deaths
- 106
- Injuries
- 609
- Malfunctions
- 1,470
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-03-15Open, ClassifiedProcess control
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
- 2023-03-15Open, ClassifiedProcess control
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
- 2013-06-08TerminatedProcess change control
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s
- 2012-05-30TerminatedComponent design/selection
Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.
Defective product may result in decreased efficacy.
- 2012-05-09TerminatedDevice Design
Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.
- 2011-11-16TerminatedSoftware design
Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
- 2011-06-28TerminatedSoftware design
Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
An additional air detection system is being added to all existing systems to detect air in the system's return line.
- 2011-05-16TerminatedPMA
The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
Operating Manual of the AS 104 Blood Cell Separator is being updated to eliminate any reference to Red Blood Cell (RBC), C4Y, P1Y and BMSC sets. This is a corrective action and recall expansion of Z-0616-2011.
- 2010-12-16TerminatedDevice Design
Fresenius Red Blood Cell Set, Catalog Number 9007601. The product is labeled in part: "RBC 9007601...STERILE...FRESENIUS KABI...Made in the Netherlands". Intended use: The Fresenius RBC red blood cell set (Art./Cat. No. 9007601) is used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
Potential for patient hematocrit dropped to levels lower than expected post-treatment.
- 2007-10-31TerminatedSoftware design
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
Monitor separator, automated, blood cell and plasma, therapeutic automatically
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