[62907621]
On (b)(6) 2016, the cdc and (b)(6) were notified of a potentially contaminated organ preservation solution identified by a transplant program on (b)(6) 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 (http://www. Organ-recovery. Com/news) and take the following steps: do not use sps-1 from the following lots: o pbr-0074-330, expiration 07/01/2018, o 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 mfr, organ recovery systems. For any quality issues or post-transplant adverse events among pts who received organs treated with one of the suspected lots since october 4, 2016: notify local or state health authorities, file a report with fda's medwatch safety info and adverse event reporting program either online (www. Fda. Gov), by regular mail or by regular mail or by fax to 1-800-fda-0178 if you suspect contaminated organ preservation products at your facility. See scanned pages.
Patient Sequence No: 1, Text Type: D, B5