FDA MedWatch - SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination

AUDIENCE: Surgery, Infectious Disease, Transplantation, Risk Manager

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 Recovery Systems has recalled SPS-1 Lot Numbers PBR-0060-392, PBR-0074-330, PBR-0074-337, and PBR-0060-386.
  • Inspect your shelves and immediately remove these products from your inventory.
  • Return the affected lots to Organ Recovery Systems.
  • If there are questions about this recall, contact Organ Recovery Systems at 847-824-2421.
• Consider quarantining existing lots of SPS-1 not included in the recall and use an alternative FDA-cleared product until Organ Recovery Systems 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 odor, the absence of an odor does not rule out the potential for bacterial contamination.
• If your 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 odor, 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Safety Communication, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm545835.htm

---

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)