The FDA today warned of issues associated with contaminated SPS-1 static organ preservation solution from Organ Recovery Systems.
The solution is intended for the flushing and cold storage of the kidney, liver and pancreas at the time of organ removal from the donor to prep for storage, transportation and eventual transplantation.
Staff at a healthcare facility last December notified the FDA of “an uncharacteristic odor” from SPS-1 during an organ procurement operation.
The FDA tested a sample of the SPS-1 fluid in question and found it was contaminated with Pantoea and Enterococcus bacteria. The agency said that it was not known how the SPS-1 which was tested became contaminated.
In response to the testing, Organ Recovery Systems initiated a voluntary removal of 2 lots of SPS-1 with lot numbers PBR-0060-392 and PBR-0074-330 in response to the test.
In January, Organ Recovery System notified customers of another report of uncharacteristic odor from a separate lot of SPS-1, lot number PBR-0074-337. Lot numbers PBR-0074-337 and PBR-0060-386 were eventually also added to the recall.
Production was suspended shortly after the recall, according to the FDA. The company updated yesterday, saying its additional random sterility testing of SPS-1 bags should be completed by the end of the month.
The federal watchdog indicated that there have been no reports of post-operative infections or other adverse events directly linked to the identified products.
The FDA suggested customers with the devices examine stock for recalled lots and consider quarantining existing lots not included in the recall until additional assurance is provided from Organ Recovery Systems.