On (b)(6) 2014 the patient was seen in the emergency room (er) for lethargy and fever of 104.7.He was taken to the operating room for a cystoscopy and stent placement for an infected ureteric stone.Postoperatively, the patient was admitted to the icu, and was critically ill with positive fungal blood cultures, as well as acute kidney failure.The patient required intubation, and hemodialysis was initiated.The patient's status slowly improved and he was transferred to a medical unit on (b)(6) 2014.While receiving hemodialysis on (b)(6) 2014, the patient went into cardiopulmonary arrest.He received >35 minutes of advanced cardiac lift support.He was transferred back to icu.The patient's family made the decision to stop life sustaining measures.The patient died on (b)(6) 2014.
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This report is being submitted as part of a system level review; if any additional information is obtained a supplemental report will be submitted.Medical records information review: this event is being reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the products and the event.There is no history of specific malfunction or product being out of specifications.The patient's multiple significant and severe co-morbidities may have resulted in his cardiopulmonary arrest and subsequent death after life support was removed.Plant investigation: complaint sample is not available, and the lot number of product involved in this incident is unknown.However, a three month sales and shipping search to the client site was performed and 13 lots were identified.According to the sap system no product is available from these lots on distribution centers to be analyzed.The entire lots have been sold and distributed.A dhr review was performed on potential related lots.No nonconformances reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.There were no alleged product malfunctions or evidence that this device caused or contributed to the reported event.
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