Model Number HQV 1806-1 |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Device has not been received for evaluation.Reference exemption # (b)(4).Importer: (b)(4).
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Event Description
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According to the hospital: "clot formation in arterial filter at full heparinization during ecc waste of the arterial satisfaction, without the blood flow was reduced, or no increase delta p oxygenator change of hlm incl.Set" ref.: #(b)(4), customer ref.: #(b)(4).
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Event Description
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Ref.: #(b)(4), customer ref.: #(b)(4).
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Manufacturer Narrative
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Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Device has not been received for evaluation.Reference exemption # e2018002.Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).
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Search Alerts/Recalls
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