BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problem
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 01/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: 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 the twist clamp of a minicap extended life pd transfer set was unable to close; further described as the ¿clamp cannot be closed completely, no leak occurred¿.This was observed during 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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Additional information was received for h3, h6, and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.A review of the photo did not show visual evidence of the reported issue; the twist clamp indent was fully engaged in the locked position.The reported condition was not verified.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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