BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problem
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 02/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: additional initial reporter phone no.(b)(6).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 separation between the female connector (dark blue) and main body (light blue) of the minicap transfer set.The event was further described as ¿the dark blue end part was getting loose from the light blue part of the clamp.¿ this was observed when disconnecting after completing peritoneal dialysis 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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Additional information was added to h6 and h10.H10: 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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