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 03/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that iodine leaked during use of a minicap extended life pd transfer set.The event was further described as ¿iodine leakage as the set cannot be tightly connected to mini cap¿.This occurred during use of the devices for peritoneal dialysis therapy.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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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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Manufacturer Narrative
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H10: the device was received for evaluation.A visual inspection with the naked eye noted a broken occluder feet beneath the twist clamp.Functional testing including clear passage testing was performed with no issues noted.Leak testing and clamp function testing failed due to a leak through the transfer set with the twist clamp in the closed position.The reported condition was verified.The cause of the condition could not be determined; however, exposure to chemical agents such as hydrogen peroxide, alcohol, or bleach as listed on product packaging can damage the transfer set materials.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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