BAXTER HEALTHCARE CORPORATION TITANIUM TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number T5C4325 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2021 |
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 a patient experienced a connection issue between the patient connector of a uv-flash solution transfer set and the titanium adapter.This was further described as the catheter adapter of the transfer set ¿was idled and the catheter adapter couldn¿t connect to the titanium adapter¿.This occurred during use of device for peritoneal dialysis therapy.There was no allegation against the titanium adapter and it was still 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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The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which included leak, clear passage, clamp function and no issues were noted.An integrity of the seal surface test was performed with no issues noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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