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 02/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: 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 the clamp of a minicap extended life pd transfer sets could not be closed completely.This occurred prior to the use of the device for peritoneal dialysis (pd) therapy.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information was added to h3, h6, and h10.H10: the device was returned for evaluation.Visual inspection with the naked eye noted that the white twist clamp will not fully align with the notch of the main body.Leak and clear passage testing were performed and no issues were observed.Clamp function testing was performed and the twist clamp closed not allowing flow through the set; however, the clamp with not fully lock in position.The reported condition was verified.The direct cause was determined to be a manufacturing related issue which occurred during the milling process.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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