BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problems
Failure to Disconnect (2541); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2022 |
Event Type
malfunction
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Event Description
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It was reported that a peritoneal dialysis (pd) transfer set had a connection issue between female connector and the solution line.The transfer set would not disconnect from the solution line which resulted in the female connector becoming loose from the mainbody when trying to twist the transfer set off the solution line.This occurred during use of the device for pd therapy.To resolve this 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.A visual inspection with the naked eye observed a separation between the female connector (dark blue) and main body (light blue).Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported condition was verified.The cause of the condition was determined to be manufacturing related caused by inadequate solvent to the main body.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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