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 02/16/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that a minicap extended life pd transfer set was difficult to disconnect from the peritoneal fluid.There was a separation between the female connector and main body of the transfer set.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 with a blue connector attached to the female connector.A visual inspection with the naked eye was performed and the female connector was observed separated from the main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.A connection and disconnection was performed using the returned blue connection and no issues were observed., therefore the reported connection issue was not verified.The reported separation between the female connector and main body was verified.The cause of the separation was due to inadequate solvent application to the set during the manufacturing process.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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