This report is being submitted as part of a system level review; if any additional info is obtained, a supplemental report will be submitted.Plant investigation: complaint sample is not available, and the lot number of product involved in this incident is unk.However, a three month sales and shipping search to the client site identified the lots shipped to the site.According tot he sap system no product is available from these lots on distribution centers to be analyzed.The entire lots have been sold and distributed.Dhr review was performed on the identified lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specs.No conclusion can be drawn regarding the complaint without an examination of the product used during the reported event.The event reported on this pt involves six separate products.Medical records review: the pt experienced a cardiac arrest during hemodialysis.This event will be reported as a serious injury, although it is undetermined if there is a reasonable suspected causal relationship between the product(s) and the event of cardiac arrest.There is no history of specific malfunction or products being out of spec.
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