[65307344]
Product use error: our transplant surgeon, dr. (b)(6), was notified by the (b)(6) program representative on friday evening (b)(6) 2017 with the following information. (b)(6) donor id (b)(6) had been allocated to the (b)(6) hospital for children transplant program for a liver transplant. Our recipient was transplanted with the liver from donor id (b)(6) on (b)(6) 2016. The preservation solution used for this organ recovery was from sps lot number pbr0060-386. We were notified that this was one of the lots of preservation solution that had been recalled due to potential contamination on (b)(6) 2017. Our surgeon notified the (b)(6) donor program representative at that time that our recipient had expired within a few days of liver transplantation. Our liver transplant recipient was a child who had been in the hospital for several weeks with several upper g. I. Hemorrhages that had only been partially controlled by sclerotherapy. She had a large number of exception points in the (b)(6) system and we felt that the donor organ was suitable for the transplant. After the donor liver was recovered in standard fashion, the liver was stored for approximately eight hours before reperfusion in our recipient. The immediate postoperative doppler ultrasound did not identify hepatic artery patency and the patient was taken back to the operating room for exploration. The patient was also relisted for liver transplant due to the known problems that hepatic artery thrombosis can cause, specifically extensive hepatic injury. In the operating room, the hepatic artery was thrombosed. The thrombus was cleared and perfusion of the liver was restored after reconstruction of the hepatic artery. There was a doppler flow study of the liver in the operating room and in the postoperative period that demonstrated the artery to be patent. However there was evidence of liver injury noted over the next 24 hours. During this time, the patient remained stable. However at 72 hours, the patient had a change in her neurologic status with pupillary dilation. A ct scan of the brain showed herniation of the brainstem. Subsequently, the patient underwent a brain death evaluation and the first examination revealed no response but failed the apnea test. However, the patient did not receive the second brain death exam due to intervening hypotension and cardiac arrest. An autopsy was performed. The autopsy findings are as follows: liver (massive hepatic necrosis, panlobular to centrilobular, most consistent with ischemia) and (neuro) diffuse ischemic/anoxic encephalopathy and cerebellar tonsillar softening consistent with herniation. In reviewing the patient's medical record, there was only one positive blood culture in the immediate postoperative period. This central line culture was positive for gram-positive cocci subsequently identified as coag negative staph. There were no other positive blood cultures or peritoneal cultures. Although there were no cultures which confirmed an infection that could have been transmitted by the preservation solution, it is possible that a gram negative rod infection and associated lipopolysaccharide release could have occurred and would certainly have resulted in a much more devastating injury to the liver than simple hepatic artery thrombosis alone. It would be most helpful if other units from this lot (pbr0060-386) could be tested for gram negative bacteria and lipopolysaccharide. We have confirmed with our local organ procurement agency ((b)(6) program ) that no solution remains from this lot that could be tested. Diagnosis or reason for use: liver transplant - donor liver preservation solution.
Patient Sequence No: 1, Text Type: D, B5