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 02/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient experienced difficulty opening and closing the twist clamp of a minicap transfer set; the patient was unable to lock the twist clamp.The nurse was able to fully close the clamp of the transfer set; however, the nurse did experience resistance.To resolve the issue, the transfer set was replaced.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 and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including leak, clear passage, and clamp function testing, and no issues were noted.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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