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 03/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name: (b)(6).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 there was a connection issue between the patient connector of a minicap extended life pd transfer set and the titanium adapter.This was further described as "thepatient connector cannot be connected¿ to the adapter.This was observed during use of the devices for peritoneal dialysis therapy.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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H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.Integrity testing was performed between patient adapter and an in-lab titanium adapter; there was no connection issue or leak observed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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