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 a loss of prime occurred more than 3 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 date of submission (b)(6) 2016 device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: the history indicated that multiple loss of prime alarm warnings were observed in the black box history associated with low non-zero force.The pump was exercised for 24 hours and the loss of prime issue was not duplicated.The force calibration passed within specification.
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Search Alerts/Recalls
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