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 Date 11/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that the twist clamp of two (2) peritoneal dialysis (pd) transfer sets were unable to close; further described as ¿couldn¿t close properly at the twist clamp and there was an obvious gap observed¿.This was observed during set up 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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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Two (2) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional tests which included leak, clear passage, and clamp function tests were performed with no issues noted.Torque engagement testing was performed, the engage and disengage force 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 reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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