The patient/user of the fmc dialysis device called tech support because she encountered an alarm that advised her to power off and call service.She was unable to get the alarm type, but she did say it was red.During the call, she mentioned that she was in the hosp for peritonitis.
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The actual device was not returned for eval and therefore, the reported event could not be confirmed or replicated.During a follow up phone call, the patient's peritoneal dialysis nurse states that the peritonitis was caused by touch contamination and not the use of the newton cycler.The fmc pharmacovigilance physician concludes peritonitis is a known serious complication of peritoneal dialysis and ther is no reported device malfunction.This is a retrospective mdr being submitted by fresenius med care as a remediation action committed to fda regarding all potential adverse events received between 21 march 2011 and 11 march 2013.
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