BAXTER HEALTHCARE CORPORATION MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number 5C4482 |
Device Problems
Failure to Disconnect (2541); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/30/2022 |
Event Type
malfunction
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Event Description
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It was reported that the female connector (dark blue) separated from the light blue mainbody of a transfer set.This issue occurred when the patient was disconnecting from the solution bag.The transfer set was connected to a solution bag and were not able to disconnected from solution bag after treatment.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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Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the sample was received for evaluation with a blue connector attached to the female connector.A visual inspection with the naked eye noted the female connector separated from the main body.Functional testing including leak, clear passage, and clamp function testing were performed with no issues noted.The reported separation between the female connector and main body was verified.The cause was related to the manufacturing process.The report of connection to female connector 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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