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 12/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: 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 a peritoneal dialysis (pd) transfer set was unable to close; further described as "clamp cannot be completely closed".This was observed during use of the device for 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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The device was received for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional tests including leak, clear passage, clamp function and torque engagement tests were performed with no issues noted.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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