Model Number 816571 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).As per the manufacturer's sale representative, when the pump is being primed the tubing is cold and stiff sometimes causing the belt slip alarm.The alarm is intermittent and goes away once the tubing is warmed up when priming.
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Event Description
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It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, there was a belt slip alarm.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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Evaluation is in progress, but not yet concluded.The field service representative (fsr) installed a loaner pump.The unit operated to the manufacturer's specification.The suspect unit was returned to the manufacturer for evaluation.
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Manufacturer Narrative
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The reported complaint was confirmed.The service repair technician (srt) could not duplicate the reported complaint condition.He replaced the drive belt as a precaution and most likely cause of the reported complaint.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Manufacturer Narrative
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Per data log analysis, the complaint indicates the issue occurred on (b)(6) 2018, but there are no log entries for that date.The log does show underspeed (head < demand) 3 times on (b)(6) 2018, 2 times on (b)(6) 2018, and 2 times on (b)(6) 2018.This will cause the belt slip message as reported.It is possible this event is being caused because the pump is over occluded.During laboratory analysis.The product surveillance technician (pst) observed ¿underspeed¿ then ¿beltslip¿ message begin to appear on pump display only when pump occlusion was adjusted to 80 clicks past optimal occlusion (over occluded) tested pump for belt slip error condition with pump jam test fixture and observed pump to generate expected results.
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Search Alerts/Recalls
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