Model Number 1261.20 |
Device Problems
Malposition of Device (2616); Positioning Problem (3009)
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Patient Problem
Pleural Effusion (2010)
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Event Date 03/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device involved in this event will be returned to vggon for evaluation as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of its conclusion via follow-up mdr.
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Event Description
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Deteriotion of respiration and hemodynamics, suspicion of malplaced catheter.Therefore, the idea of pleural drainage was born.
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Manufacturer Narrative
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It was not possible to flush the catheter because of several occlusions.A thoroughly microscopic step by step examination showed a lot of fibrins adhering to the catheter tube but no defect could be detected which might have led to a leakage.This is the second complaint for batch 040817gj (co-2018-0307 - same customer), the 35th complaint for a leaking catheter tube on code 1261.20 and the 5th regarding inflammation or phlebitis with code 1261.210 within the last 3 years but none of these complaints manufacturing related.This is the first complaint on code 1261.20 regarding oedema within the last 4 years.
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Event Description
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Deteriotion of respiration and hemodynamics, suspicion of malplaced catheter.Therefore, the idea of pleural drainage was born.
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Search Alerts/Recalls
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