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 09/04/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Patient age: 77.Patient weight: 70.9.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 a minicap transfer set could not be disconnected from the patient line of a homechoice cassette which resulted in separation between the female connector and main body of the twist clamp of the transfer set.This was further described as ¿you could see the tubing between the light blue plastic and the dark blue plastic¿.This occurred after use of the device for peritoneal dialysis (pd) therapy.To resolve the 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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H10: the device was received for evaluation with an amia patient connector attached to the female connector.During visual inspection, the female connector was observed separated from the main body.Functional testing was performed which included leak testing, clear passage testing, and clamp function testing, and the set performed according to product specifications.No leak was observed.Therefore, there was no risk to the patient as the separation of the transfer set did not result in a breach in the sterile pathway.The reported condition was verified.The cause of the separation was due to inadequate solvent application during manufacturing.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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