Model Number 2426-0007 |
Device Problem
Reflux within Device (1522)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Although requested, patient demographics not provided.
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Event Description
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It was reported that a back check valve failed.There was no pump failure but the infusion line had the same level volume as the bag, whether raised or lowered, suggesting a failed check valve meaning the fluid potentially went into the bag and not into the patient.Although requested, no further information has been received.
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Event Description
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It was reported that a back check valve failed.There was no pump failure but the infusion line had the same level volume as the bag, whether raised or lowered, suggesting a failed check valve meaning the fluid potentially went into the bag and not into the patient.Although requested, no further information has been received.
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Manufacturer Narrative
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The customer complaint of back check valve could not be confirmed due to the product not being returned.The photo of the returned set observed fluid levels on both iv lines to be equal in fluid indicating a possible back flow.The root cause was not identified.
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Search Alerts/Recalls
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