Catalog Number ASKU |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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 peritoneal dialysis (pd) transfer set had a connection issue; further described as ¿when trying to twist the patient line to the transfer set line it makes a click sound, almost like something breaking and when it clicks it also feels like it wants to pop off¿.The patient held and continued to twist the connection until secured.This occurred during use of the devices for peritoneal dialysis (pd) therapy.The transfer set was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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 peritoneal dialysis (pd) transfer set had a connection issue; further described as ¿when trying to twist the patient line to the transfer set line it makes a click sound, almost like something breaking and when it clicks it also feels like it wants to pop off¿.The patient held and continued to twist the connection until secured.This occurred during use of the devices for peritoneal dialysis (pd) therapy.The transfer set was replaced.There was no report of 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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