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 11/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 twist clamp of the minicap transfer set was unable to close; further described as ¿unable to close the twisted clamp tightly." 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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H10: the device was received for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.Torque engagement testing was performed; the engage and disengage force to open and close the twist sleeve was acceptable and met specification.The reported condition was not verified.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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