Bulletin 17-2

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Information Regarding Reports of Contaminated SPS-1 ® Static Preservation Solution

Bulletin 17-2

January 13, 2017

Yesterday (January 12, 2017), Organ Recovery Systems, Inc. (ORS) posted a news update to their webpage regarding reports of Contaminated Organ Preservation Fluid - SPS-1®. ORS is in the process of conducting a comprehensive investigation of available information and indicated all of their customers have been notified via email. ORS is temporarily suspending production of SPS-1® and will not be making further shipments of potentially affected Lot Number PBR-0074-337 and Lot Number PBR-0060-386 pending the conclusion of their investigation. The full ORS news update can be accessed here.

Additionally, the Organ Procurement and Transplantation Network (OPTN) published a patient safety alert on their news page citing a report from the Centers for Disease Control and Prevention (CDC) which was released on January 12, 2017 through the Epidemic Information Exchange (Epi-X) and reads in part:

This is an update to an EPI-X posted on December 16, 2016, which reported potential contamination in SPS-1 lots PBR-0074-330 and PBR-0060-392. Product from these lots has now been voluntarily removed from circulation by the distributer.

On January 11, 2017, the CDC and FDA were notified by a transplant center in Texas that SPS-1 preservation solution used during an organ procurement procedure had a foul odor. Cultures of the preservation solution were obtained and reported to have grown Gram-negative rods. The SPS solution came from lots PBR-0074-337 and PBR-0060-386, which are different from those previously implicated.

Since SPS-1® is used to flush organs before recovery, there is a potential concern that recovered tissues could also possibly be affected.

SPS-1® users should refer to OPTN's patient safety alert for recommended actions. Should you have additional questions or comments, please do not hesitate to contact mcopithorne@organ-recovery.com or your Organ Recovery Systems, Inc. account representative.