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 Type
malfunction
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Event Description
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It was reported that a minicap transfer set and homechoice cassette had a connection issue; further described as transfer set would not disconnect from the patient line which resulted in separation between the female connector and main body of the transfer set.This occurred during an unspecified process step of peritoneal dialysis therapy.The patient cut the patient line and went to the emergency room to replace 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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Additional initial reporter phone no.: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information: h3, h6, h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection with the naked eye noted the female connector separated from the main body.The reported condition was verified.The cause of the condition is related to inadequate solvent application during manufacturing.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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Search Alerts/Recalls
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