BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number ASKU |
Device Problems
Failure to Disconnect (2541); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
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 there was a separation between the female connector (dark blue tip) and the main body of the twist clamp on a minicap transfer set.This was described as ¿the internal connection on the transfer set started to come unscrewed¿.Additionally, the transfer set connector was completely affixed to the patient line of the cassette; further described as there was ¿no ability to separate the two¿.The patient¿s caregiver cut the patient line in order to disconnect the two.This was observed while disconnecting after peritoneal dialysis (pd) therapy.The transfer set was replaced to resolve the issue.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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