Unknown manufacturer: (b)(6).Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Material number and batch number is unknown; a lot history review could not be performed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa is not required at this time.
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It was reported that unspecified bd¿ syringe was used and the patient experienced feeling cold near the end of the session, had a temperature of 37.5, and then a pre washback temperature of 37.9.The following information was provided by the initial reporter: we have had a small number of patients in the last few weeks who have had rigors and/or fever towards the end of their haemodialysis/apheresis session or just after disconnection.All patients affected have central venous catheters.Cultures and infection screens are reported negative."c/o feeling cold++ near end of session, temp 37.5, pre washback temp 37.9".
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