BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER ADSORBA 150C; APPARATUS, HEMOPERFUSION, SORBENT
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Catalog Number 115263 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/01/2019 |
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 during priming of an adsorba 150 c unit, foreign matter was observed.The set was replaced.There was no patient involvement with the reported event.No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, two photographs and a video of the sample were provided for evaluation.Visual inspection of the two provided photos did not identify any abnormalities that could have contributed to the reported condition.Visual inspection of the provided video showed black particles in the deaeration chamber were visible.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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