Model Number 2420-0500 |
Device Problem
Reflux within Device (1522)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the affected product be received for evaluation.Although requested, patient demographics not provided.
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Event Description
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The customer reported that a secondary infusion of zosyn (3.375 grams in 50ml) was noted to be back infusing into primary bag of 0.9% sodium chloride.The pump was programmed to infuse at 200ml/hr.There was no harm.
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Event Description
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The customer reported that a secondary infusion of zosyn (3.375 grams in 50ml) was noted to be back infusing into primary bag of 0.9% sodium chloride.The pump was programmed to infuse at 200ml/hr.There was no harm.
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Manufacturer Narrative
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The customer¿s report of backflow was not confirmed.No anomalies were observed during visual inspection.The check valve was visually inspected under magnification and was found to be assembled in the set correctly with the silicone membrane centered.Functional testing was performed; no backflow into the primary bag was observed.The check valve component was returned to the supplier for additional analysis.Testing indicated a pass result.Disassembly of the check valve resulted in normal findings.There were no particulates noted on the diaphragm membrane, no solvent in the check valve component, and no damages to the interior of the check valve or the diaphragm.The root cause of the reported backflow was not identified.
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Search Alerts/Recalls
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