Patient Safety Alert – Reports of Contaminated Organ Preservation Solution
The CDC, Healthcare Resources and Services Administration (HRSA), Food and Drug Administration (FDA), and Iowa Department of Public Health (IDPH) are investigating a report of bacterial contamination of the organ preservation solution SPS-1, manufactured by Organ Recovery Systems (ORS).
On December 14, 2016, the CDC and IDPH were notified of a potentially contaminated organ preservation solution identified by a transplant program on December 12, 2016. Surgeons noted a foul odor emanating from the organ preservation solution. Samples obtained from several opened bags grew Gram-negative and Gram-positive bacteria, including Pantoea agglomerans and Enterococcus casseliflavus.
The organ preservation solution, SPS-1, is manufactured by Organ Recovery Systems (ORS). Bags with microbial growth were reported from two lots.
All Organ Procurement Organizations and Organ Transplant Centers should be aware of the concern for potential polymicrobial contamination of two lots of SPS-1 and take the following actions.
- Do not use SPS-1 from the following lots:
- PBR-0074-330, expiration 07/01/2018
- PBR-0060-392, expiration 06/01/2018
Immediately recover any unused product. Sequester product in such a way that it is secured and not prone to further distribution or use within the facility. Return these products to the manufacturer, Organ Recovery Systems.
For any quality issues or post-transplant adverse events among patients who received organs treated with one of the suspected lots:
- Notify local or state health authorities.
- File a report with FDA’s MedWatch Safety Information and Adverse Event Reporting Program
- Submit a report to the Organ Procurement and Transplantation Network in the Disease Transmissions section of the Improving Patient Safety portal in UNet.
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