ISSUE: On Dec. 14, 2016, staff at a health care facility notified the FDA of an uncharacteristic odor from SPS-1 encountered during an organ procurement operation. Laboratory results from fluid samples and cultures from the SPS-1 used for this operation confirmed contamination with Pantoea and Enterococcus (intrinsically vancomycin-resistant) bacteria.
While it is not yet known how the SPS-1 used for this operation became contaminated, Organ Recovery Systems immediately initiated a voluntary removal of two lots of SPS-1: Lot Numbers PBR-0060-392 and PBR-0074-330.
On Jan. 12, 2017, Organ Recovery Systems notified customers of another report of an uncharacteristic odor from SPS-1 from a different lot, Lot Number PBR-0074-337, suggestive of potential contamination. Additionally, SPS-1 from Lot Number PBR-0060-386 was reported as being present when an odor was noticed, although the report did not identify any odor coming directly from this product.
Since then, Organ Recovery Systems temporarily suspended production and distribution of all SPS-1 products, and added Lot Numbers PBR-0074-337 and PBR-0060-386 to their recall.
On March 8, 2017, Organ Recovery Systems updated customers on the voluntary removal of SPS-1 and stated that additional sterility testing of randomly selected bags of SPS-1 should be completed by March 31, 2017.
To date, there have been no reports to the FDA of any post-operative infections or other adverse events directly linked to the identified products.
BACKGROUND: SPS-1 Static Preservation Solution (SPS-1), manufactured by Organ Recovery Systems, Inc., is a clear to light yellow, sterile solution intended for the flushing and cold storage of kidney, liver, and pancreas at the time of organ removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
The FDA is working with the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and state public health departments to actively investigate the potential for contamination in Organ Recovery Systems’ SPS-1.
RECOMMENDATION: In addition to following the standard precautions, the FDA recommends facilities and staff:
- Be aware that Organ Re...