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 Type
malfunction
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Manufacturer Narrative
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E1: (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 a minicap transfer set had a connection issue; further described as ¿the transfer set cannot be tightly connected to the tenckhoff catheter." this was observed during use of the devices for peritoneal dialysis therapy.The transfer set was replaced, however 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: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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