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 02/12/2024 |
Event Type
malfunction
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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.The event was further described as ¿can hardly close it and did not want to go into the notch without using a lot of force; twisting mechanism was really stiff.¿ 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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E1: initial reporter address: (b)(6).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.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional tests including leak, clear passage, and clamp function tests were performed and no issues were 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 reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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