BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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Catalog Number ASKU |
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 Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(4), dalin township.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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 had a connection issue resulting in iodine leakage.The event was further described as ¿transfer set can¿t fit tightly with the minicap, and the iodine leak out¿.This occurred during use of the device for peritoneal dialysis therapy.There was no damage noted on devices.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: the device was received for evaluation with a transfer set.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing was performed on the returned minicap with an in lab female connector with no leak observed between the connection.The device was conforming product.The reported condition was not verified during evaluation of the returned minicap.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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