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Device Problems
Component Falling (1105); Disconnection (1171); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/14/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Based on the reported event description, the cause of the reported issue was determined to be a loose connection.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The home patient (hp) was connected at the time of the alarm.This occurred during dwell two of five of peritoneal dialysis therapy.During troubleshooting, the care giver (cg) stated that the final bag came loose, disconnected, and fell.Proper procedures were reviewed with the customer.The technical service representative advised the cg that the hp must start therapy over with new supplies or use manual supplies to complete therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Search Alerts/Recalls
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