BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4483 |
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 Type
malfunction
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Event Description
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It was reported that the twist clamp of a minicap transfer set was "unable to close properly".This was observed during set up of the device for peritoneal dialysis therapy.The transfer set was replaced.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The event occurred on an unspecified date in (b)(6) 2022.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the sample was received for evaluation with a cap attached to the female connector and twist clamp in closed position.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 and there were no issues.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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Search Alerts/Recalls
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