BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 112466 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Diarrhea (1811); Vomiting (2144)
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Event Date 08/26/2019 |
Event Type
Injury
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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 within 30 minutes of dialysis treatment with a polyflux 170h, the patient experienced vomiting, diarrhea and abdominal pain.Treatment was stopped immediately.The patient was treated with given bao xin pills.Ten minutes later, the symptoms disappeared and treatment was continued.The polyflux was observed to have clotted after five minutes of treatment and therefore the treatment was stopped.No additional information is available.
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Manufacturer Narrative
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Additional information:h6 and h10.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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Search Alerts/Recalls
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