[110360819]
Physicians and procurement staff were involved in a lung recovery procedure. The perfadex preservation solution was transported to the facility in a cooler. One bag of solution was infused during the recovery and a second bag was prepped for infusion after the lungs were recovered. After approximately half of the fluid was infused from the second bag, a small hole was discovered in the top portion of the bag. The recovering surgeons were informed about the incident as well as the transplanting surgeon and the decision was made to continue with the procedure. The hole was very small and only a small stream of fluid leaked from the bag when pressure was applied. A report was filed with the united network for organ sharing (unos) pt safety portal. The mfr (xvivo perfusion) has been contacted (and responded quickly) as well. Although the mfr denied any current product recall notices (i had also verified recalls on the fda site), they did state that as of 2018, they have a new bag design that will hopefully eliminate future incidences. We will continue to monitor the pt closely. At present, the pt is recovering without incident. Suspect: yes; primary: yes; product type: drug/biologic. Dose or amount: 2800 ml millilitre(s), frequency: one time, route: intravenous. Strength: na ml millilitre(s). Therapy duration: 20 year. Reason for use: lung preservation during organ recovery.
Patient Sequence No: 1, Text Type: D, B5