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 12/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that the white twist clamp of a minicap extended life transfer set would not close but "would go in a circle".This was observed after peritoneal dialysis therapy.To resolve the issue, the transfer set will be replaced.There was no 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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H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak testing, clear passage testing and clamp function testing 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.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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