BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number ASKU |
Device Problems
Fluid/Blood Leak (1250); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(4).The devices were 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 there was a connection issue between an unspecified quantity (at least 2) of minicaps and the female connector of two (2) minicap extended life pd transfer sets which resulted in iodine leakage.The connection issue was further described as ¿the set cannot be fit with mini-cap¿.This occurred during use of the devices for peritoneal dialysis therapy, after closing the twist clamps of the transfer sets.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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