Important Safety Alerts

The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning SPS-1 Static Preservation Solution [Lot Numbers: PBR-0060-392, PBR-0074-330, PBR-0074-337, and PBR-0060-386], manufactured by Organ Recovery Systems, Inc.

On December 14, 2016, staff at a health care facility notified the FDA of an uncharacteristic odour 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, the manufacturer immediately initiated a voluntary removal of two lots of SPS-1: Lot Numbers PBR-0060-392 and PBR-0074-330.

On January 12, 2017, the manufacturer notified customers of another report of an uncharacteristic odour 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 odour was noticed, although the report did not identify any odour coming directly from this product.

Since then, the manufacturer 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, the manufacturer 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.

In addition to following the standard precautions, the FDA recommends facilities and staff:

• Be aware that Organ Recovery Systems has recalled SPS-1 Lot Numbers PBR-0060-392, PBR-0074-330, PBR-0074-337, and PBR-0060-386.
• Inspect shelves and immediately remove these products from inventory.
• Return the affected lots to the manufacturer.
• Consider quarantining existing lots of SPS-1 not included in the recall and use an alternative FDA-cleared product until the manufacturer provides additional assurance of product safety through additional sterility testing.
• Be aware that while contaminated SPS-1 to date has been associated with an uncharacteristic odour, the absence of an odour does not rule out the potential for bacterial contamination.
• If the facility does not have an alternative organ preservation solution immediately available, the FDA does not believe that organs exposed to SPS-1 should be excluded from transplantation. Rather, the small risk of infection should be balanced with the benefits of transplantation in each potential recipient.
• Pay attention to the quality of any organ preservation solution used. If there are concerns about odour, cloudiness, precipitation, or any other physical characteristics that could indicate contamination, carefully consider the benefits and risks.
• Report any adverse events or suspected contamination of organ preservation solution to the FDA and the manufacturer.

For details, please refer to the FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm545835.htm
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm545810.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 10 March 2017