MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
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Model Number MMT-754WWS |
Device Problems
Filling Problem (1233); Fluid/Blood Leak (1250); Failure to Prime (1492); Material Protrusion/Extrusion (2979)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/31/2018 |
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
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Event Description
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Customer reported via phone call prime fill issue.The customer's blood glucose was 6.0mmol/l at the time of call.Trouble shooting was performed insulin is squirting out during prime process.Customer was unable to successfully prime a new infusion set.Customer stated the drive support cap is protruded.Advised the insulin pump will need to be replaced.Advice to discontinue use of the insulin pump and revert to backup plan.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Unit alarmed motor error during the basic occlusion test due to loose/flushed drive support disk.Unable to perform operating basic occlusion test, occlusion test, prime/delivery test, excessive no delivery test or verify compromised force sensor alarm due to motor error alarm.
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Search Alerts/Recalls
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