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Model Number MZ9226 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/21/2019 |
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 information was not provided.
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Event Description
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It was reported that five minutes after starting lasix infusion, the pump gave occlusion alarm.After assessing the tubing it was found that a small amount of fluid was leaking at filter.The tubing was changed and the medical team was notified.The event occurred in neonatal icu.There was no patient injury.Although requested, additional information was not provided.
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Event Description
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It was reported that five minutes after starting lasix infusion, the pump gave occlusion alarm.After assessing the tubing it was found that a small amount of fluid was leaking at filter.The tubing was changed and the medical team was notified.The event occurred in neonatal icu.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.Although requested, additional event information was not provided.
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Manufacturer Narrative
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Additional information added; d10, & d11.The customer¿s report of a leak at the filter was confirmed based on visual inspection and functional testing.The set's micron filter's air vent membrane was wetted/compromised and a leak (termed ¿weeping out¿) was observed from the same area.The set was inspected for kinks, holes/tears in the tubing or damages to the components.Functional testing was performed by pushing fluid through from the syringe.There was slight resistance observed during the push.The fluid was observed to exit the set's male luer end as expected and leak out from the filter vent.No other leak was observed.The root cause of the observed leak from the filter vent was not identified.The customer's other report that the pump gave an occlusion alarm was likely to have occurred due to the observed resistance during the fluid push.The root cause of the occlusion was not identified.
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Search Alerts/Recalls
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