Model Number MZ1000 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problems
Extravasation (1842); No Consequences Or Impact To Patient (2199)
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Event Date 04/24/2019 |
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 device be received for evaluation.
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Event Description
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Feedback suggests that there was an extravasation injury.The customer reported that the piston had folds and torsion when connected to with syringes and after infusion extravasation was identified.
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Event Description
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After further investigation and clarification with the affiliate, it has been determined that the original report was incorrect.The extravasation incident report has been retracted.The actual confirmed event does involve the ¿piston¿ of the maxzero, but was a leak due to a stick down of the piston involving ¿splashing¿ or leakage from the maxzero when the syringe was removed.No patient or user harm in this incident.
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Manufacturer Narrative
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No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
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Search Alerts/Recalls
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