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 09/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that a minicap transfer set had a connection issue; further described as ¿unable to disconnect drain bag from the transfer set¿.This occurred after treatment of peritoneal dialysis therapy, during disconnection.The navy tip (female connector) "unscrewed from the roller clamp" (mainbody).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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E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: 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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Search Alerts/Recalls
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