BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 the twist clamp on a peritoneal dialysis (pd) transfer set would not close.This issue was further described as, ¿white twist clamp would not lock¿.This occurred during used of the device for pd therapy.To resolve this 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 sample was received for evaluation with a mini cap.A visual inspection with the naked eye noted a broken occlude feet on the light blue main body.The broken occlude feet would create difficulty in closing the transfer set.The reported condition was verified.The cause of the crack/damage was undetermined; however, was consistent with damage caused by exposure to chemical agents such as foreign solvents, dyes, or cleaning agents that damage the transfer set materials.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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