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
Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/28/2018 |
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.The device has been returned, but not yet evaluated.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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It was reported that the customer's insulin pump had alarmed compromised force sensor system.The customer¿s blood glucose level was 279 mg/dl at the time of the incident.The customer also reported that they received a compromised force sensor system alarm and insulin was squirting during manual prime process.The customer was asked customer verbally and in written form to return broken pump for analysis.The insulin pump will be returned for analysis.
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Manufacturer Narrative
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Device received compromised force sensor system alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform basic occlusion test, occlusion test, prime test, excessive no delivery test due to compromised force sensor system alarm.However, device passed rewind test and displacement test.
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Search Alerts/Recalls
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