Device Problem
Failure to Prime (1492)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
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Event Description
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On (b)(6) 2016, the reporter contacted animas, alleging a prime (loss of prime) issue.It was reported that the loss of prime occurred 3 or more times.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.
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Manufacturer Narrative
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Follow-up # 1 - device evaluation: the device has been returned and evaluated by product analysis on 4/13/2016 with the following findings: there was no evidence of loss of prime errors, alarms or warnings observed in the black box history.The pump successfully completed the rewind, load cartridge and prime steps with no alarms.The force sensor calibration passed within specification.The pump was exercised for 24 hours with no loss of primes occurring therefore the issue was not duplicated.Unrelated to the initial complaint, it was observed that the battery compartment was cracked.(b)(4).
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Search Alerts/Recalls
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