BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4483 |
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 04/01/2024 |
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 connector of a minicap transfer set ¿unscrewed from the transfer set¿ and the transfer set would not come apart from the patient line of the cassette causing the home patitient (hp) to cut the line.This was identified while attempting to disconnect from peritoneal dialysis (pd) therapy.The transfer set was replaced.There was no report of patient injury, however, the hp received prophylactic treatment as a preventative measure.The patient did not develop any symptoms.No additional information is available.
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Manufacturer Narrative
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H11: the device was received for evaluation with a patient connector attached to the female connector.A visual inspection with the naked eye noted a separation between the female connector and main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The returned patient connector was disconnected and connected by hand with no issues; therefore the reported condition of connection issue with female connector was not verified, however, the condition of separation between the female connector and main body was verified.The cause of the separation was due to an inadequate solvent bond between the female connector, insert chip, and main body during the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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