It was reported that a patient felt shock from the homechoice device during the therapy.The patient was connected during peritoneal dialysis therapy.The patient indicated that when they turned the device back on, after powering it off due to an unrelated issue, they felt a tingle on their finger/shock.There was no patient injury or medical intervention associated with this event.No additional information is available.
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(b)(4).Additional information: the device was received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.An internal and external visual inspection was performed and no issues were noted.Full functional testing, electrical safety testing, calibration and simulated therapy was performed.All product specifications were met.A service history record review was performed and revealed no indication that the parts replaced during servicing caused or contributed to this event.The reported issue was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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