BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problems
Fluid/Blood Leak (1250); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2024 |
Event Type
malfunction
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Event Description
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It was reported that the twist clamp of the minicap extended life pd transfer set ¿cannot be closed¿ which resulted in a leak.This was observed prior to use of the device for peritoneal dialysis therapy.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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H10: the device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the actual sample was returned for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak testing, clear passage, clamp function testing, and torque engagement were performed.No issues were observed through functional testing.The reported condition was not verified.The returned sample was determined to be a conforming product; the sample met specification.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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