Organ Transplant Solution Contamination Warning Issued by FDA

Federal health officials are warning medical professionals about the importance of inspecting certain organ transplant and storage solutions before they are used, indicating that there is a risk some of the sterile solutions may be contaminated with potentially harmful bacteria that could pose a serious risk for organ transplant patients. 

In a safety communication issued on March 9, the FDA raised concerns about some lots of SPS-1 Static Preservation Solution (SPS-1), which may be contaminated with the infectious bacteria Pantoea and Enterococcus, which can resist treatment by some antibiotics.

SPS-1 is supposed to be a sterile solution, which is clear-to-light yellow in color. It is intended for the flushing and cold storage of kidney, liver, and pancreas organs at the time of their removal, or during the preparation process for storing, transportation, and eventual transplant into a recipient.

The FDA warns that solutions have the potential to be contaminated with Pantoea and Enterococcus bacterium, which are an uncommon form of pathogen that may cause a wide variety of adverse health consequences including urinary-tract infections, meningitis, wound infections, blood infections, and other septic conditions including organ infections.

In December, a staff member at a health care facility warned the FDA that SPS-1 used during an organ procurement operation had given off an uncharacteristic odor. An investigation and laboratory testing confirmed the SPS-1 used in that operation had been contaminated with vancomycin-resistant Pantoea and Enterococcus bacteria.

Although the source of the contamination was not determined, Organ Recovery Systems, the manufacturer, initiated a recall of two separate lots of the SPS-1 solutions from the market with lot codes PBR-0060-392 and PBR-0074-330.

Following the recall, Organ Recovery Systems was notified on January 12, 2017 of another report indicating an uncharacteristic odor from a different lot number of SPS-1 solution not included in the original voluntary removal. The report prompted the manufacturer to temporarily suspend production and distribution of all SPS-1 products and has since added lot numbers PBR-0074-337 and PBR-0060-386 to the recall.

Although no reports of adverse health consequences have been linked to the products, the FDA issued a warning to customers in the medical field, particularly those dealing in organ transplant and preservation to randomly test their inventory of SPS-1 solution bags. Sterilization bags that may be potentially contaminated may produce an odd or uncharacteristic odor, but not always, according to the FDA.

The FDA is asking customers to perform additional sterility testing of randomly selected bags of all SPS-1 products prior to March 31, 2017, and to return all recalled lots to Organ Recovery Systems. For additional information and further questions regarding the recall or potentially contaminated products, please call Organ Recovery Systems at 847-824-2421.