BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2022 |
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; further described as ¿mini infusion tube cannot be separated from the solution end¿.This was observed at the patient's home during use of the device for peritoneal dialysis (pd) therapy.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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Initial reporter address: (b)(6).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 with a mini cap connected to the female connector.A visual inspection with the naked eye noted a damaged on the threads and sealing surface of the female connector.Functional testing including clear passage and clamp function testing were performed and no issues were observed.Leak testing was performed with the returned mini cap attached to the female connector and a leak was observed at the connection of the two components.The returned mini cap was hand removed from the female connector, therefore the reported connection issue was not verified.During retesting with an in lab mini cap placed on the female connector a leak was observed.The cause of the leak was due to a damaged female connector, however the cause of the damage could not be determined.A visual inspection with the naked eye noted a dark blue female connector separated from the light blue main body.The cause of the separation was due to inadequate solvent application to the main body during manufacturing.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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