Qn#(b)(4).No intra-aortic balloon pump (iabp) parts or recorder strips were returned to teleflex (b)(4) for evaluation.Per the call report, the registered nurse (rn) called the hotline because the "blue waveform on the monitor was a flat line." this most likely was caused by the helium loss alarm which is a class 1 alarm.A class 1 alarm will cause the pump to stop pumping (pump off), deflate iab, open vent valve, audio alarm, alarm message, freeze w/form - prints out on strip.The clinical support specialist (css) discussed with the rn that it is the staff's responsibility to restart pumping.The pump will not start back up by itself.Once the pump was started back up, there were no further issues with the pump.The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings.All devices passed all manufacturing specifications prior to release.See other remarks section.Other remarks: conclusion: the reported complaint of "helium loss alarms" is confirmed with the information provided to the css.The helium loss caused the pump to stop pumping.The pump was reset by the rn and the pump started pumping.There were no further issues.No iabp parts or recorder strips were returned to teleflex (b)(4) for evaluation.The cause of the reported complaint is undetermined.
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