BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2022 |
Event Type
malfunction
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Event Description
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It was reported there was a connection issue between the patient connector of a minicap extended life pd transfer set and the titanium adapter.This was observed ¿before treatment¿ for peritoneal dialysis therapy.There was no allegation against the adapter.The titanium adapter remained in use.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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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The actual devices were not available; however, a photograph of one (1) sample was provided for evaluation.A visual inspection with the naked eye noted that the transfer set in an open pouch with the blue pull ring cap over the patient connector.The reported condition was not verified.The cause of event could not be determined; with the absence of a sample for evaluation, there was not enough information to refute or confirm the allegations.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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