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 12/29/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that the twist clamp of a peritoneal dialysis (pd) transfer set was ¿unable to close¿.This was observed before 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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H10: the device was received for evaluation.Visual inspection with the naked eye observed no issues.Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues observed.Torque engagement testing was performed, the engage and disengage force was acceptable and met specification.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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