Catalog Number L5C4531 |
Device Problems
Fluid/Blood Leak (1250); Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/25/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 cassette leaked during prime of peritoneal dialysis therapy.The patient planned to restart therapy using all new supplies.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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(b)(4).The following narrative was updated to replace the event or problem: it was reported that the cassette was not sealed properly (instead of the previously reported event or problem of it was reported that cassette leaked during prime of peritoneal dialysis therapy.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 the cassette was not sealed properly.
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Manufacturer Narrative
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(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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