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 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: 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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Event Description
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It was reported that three (3) minicap extended life pd transfer sets had clamps that could not be closed, with no allegations of leakage.This was observed during use of the devices for peritoneal dialysis (pd) 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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H11: three (3) samples were received for evaluation.A visual inspection with the naked eye noted the twist clamp was not fully aligned to the notch of the main body on all three samples.Functional testing including leak and clear passage testing were performed with no issues noted.Clamp function testing observed the twist clamp closed and there was no fluid flow through all three sets; however, the detent of the twist clamp did not fully align with the notch of the main body.The reported condition was verified.The cause of the condition was determined to be manufacturing related that occurred during the milling process.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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