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 05/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(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 the female connector (dark blue) separated from the light blue main body of the twist clamp of a minicap extended life pd transfer set.The issue was described as ¿the patient could not separate the transfer set and solution bag after treatment¿; therefore the patient visited the hospital where ¿the nurse supported to separate the transfer set and solution bag but it turns out female luer separated from main body¿.This issue occurred during use of peritoneal dialysis (pd) therapy at the patient¿s home.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.A visual inspection with the naked eye noted the female connector separated from the main body.Functional testing including leak testing, clear passage testing, and clamp function testing were performed with no issues noted.The reported condition of separation was verified.The cause of the separation is related to inadequate solvent application during manufacturing.The reported condition of connection issue to the female connector was not verified.The cause of the connection issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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