MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-523LNAS |
Device Problems
Fluid/Blood Leak (1250); Failure to Prime (1492)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
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Event Description
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The customer reported via phone call the insulin pump would not exit the preparing to prime loop and insulin squirted out if the tubing during manual prime.The customer¿s blood glucose was unknown at the time of the incident.During troubleshooting, the customer changed the infusion set and reservoir, but insulin continued to drip after letting go of the act button during prime.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will not be returned for analysis.
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Manufacturer Narrative
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Device passed the displacement test, basic occlusion test, occlusion test, prime test, rewind test and excessive no delivery test.No rewind anomaly noted.Device primed properly.
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Search Alerts/Recalls
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