BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problems
Fluid/Blood Leak (1250); Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter address: (b)(6).The device was received and is currently awaiting evaluation.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 female connector of a minicap transfer set was not tightening to the cassettes which resulted in leak; further described as "switch will be released".This was observed during use of the devices for peritoneal dialysis therapy, when connecting the devices.The transfer set was replaced to resolve the event.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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B5: updated information was received stating there was no leak; further described as there was "no leak from the connection as well".Additional information was added to h3, h6 and h10.H10: the device was received for evaluation.A 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.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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