Model Number MZ1000-07 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
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Event Description
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Unexpected return; the product report from the customer states that doxorubicin leaked from the connection of the administration set to the maxzero.Upon inspection, a crack was found in the maxzero.There was no report of patient harm.
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Manufacturer Narrative
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The customer report that the maxzero valve leaked and had a crack was confirmed.Visual inspection showed a crack running along one side of the top of the valve.Functional testing showed that fluid leaked from the engagement between the syringe and the valve.The root cause of the customer's report was not identified.
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Event Description
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Unexpected return - the product report from the customer states that doxorubicin leaked from the connection of the administration set to the maxzero.Upon inspection, a crack was found in the maxzero.There was no report of patient harm.
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Search Alerts/Recalls
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