Catalog Number IAB-05840-LWS |
Device Problems
Kinked (1339); Failure to Calibrate (2440)
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Patient Problems
Myocardial Infarction (1969); Cardiogenic Shock (2262)
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Event Date 12/30/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the respiratory therapist (rt) from the cardiac care unit (ccu) was calling because they were getting alarms on the pump and no arterial pressure (ap) signal.An intra-aortic balloon (iab) was inserted via the patient's (pt) right femoral artery while in the cath lab.The pt was ventilated, sedated, in sinus tachycardia, and levophed and dopamine infusing.There were alarms on the pump when the pt returned to the ccu; pt had begun trashing.The pt was taken back to the cath lab because of the alarms.The position of the catheter was fine.They returned to the unit and continued to have issues with the helium alarms and ap waveform.The pt was switched to a second pump while in the cath lab.The pump was using the central lumen of the catheter and the arterial line was dampened.The css had the rt aspirate and flush the line.The rt said it was sluggish.The css asked the rt to put some traction on the catheter and hyperextend the hip and the arterial line improved.The css and rt discussed that the fiberoptix sensor (fos) status was pl (fos is measuring outside of pressure range).The icon was white (fiberoptix iab cal value manually adjusted).The rt did not have an ap waveform on the screen.The css had him connect the fiberoptic and the css could hear the audible tone.When the rt had the fiberoptic and cal key connected, the icon turned green (fiberoptix iab zero'd prior to insertion), but there was no waveform on the screen.The fos code was pl (fos is measuring outside of pressure range), and eo (excessive offset: zeroing procedure resulted in a large difference from factory set calibration).The css had the rt try to calibrate the fiberoptic, but the pump gave a message unable to calibrate.The css told the rt to use the central lumen of the balloon for the timing on the first pump.The rt stated message "no ap signal available" was on the pump.The central lumen waveform was much dampened.The css had the rt aspirate, flush, put traction on the catheter and reposition the pt.This did not improve the waveform.They were currently placing a radial line in pt.The css had the rt connect the radial line to the pump for timing.The pump was pumping and not alarming.The rt sent a picture which showed late deflation.The balloon pressure waveform (bpw) was not getting back to zero, but not alarming.The css had the rt decrease the volume in the balloon with no change; the bpw was not getting back to zero.When in 1:2 the bpw was not getting back to zero.The css had the rt go to operator mode and adjust the timing so that they should have late inflation and early deflation.The bpw still was not getting back to zero.The intra-aortic balloon pump (iabp) also was not alarming "possible helium loss." the css had the rt decrease the volume to 35 cc with no change.The css had the rt go to 1:4.The bpw was slow, but did get back to zero.The deflation timing looked late even in 1:4.The css had the rt power the pump off and back on with no change.The css had the rt connect the pt to a third pump and there was no change.We were about to change to a fourth pump when the third pump began alarming "possible helium loss".The third pump was in operator mode with inf lation set at 50% and deflation set at 75% and balloon volume at 35 cc.The css had the rt flush the radial line and the arterial waveform stayed the same.The css had rt check to make sure there was no blood in the gas driveline tubing and the rt said there was none.At this time it was realized that this had to be a problem with the catheter since the central lumen was not working, the fiberoptic was not working, and we could not get the bpw to come back to baseline.The css recommended they change the catheter.It appeared to the css that the pump could not get the helium back out in time and was causing the late deflation appearance on the arterial waveform.The rt agreed with the css and was going to discuss with the physician.A second call was received at 7:27am mt.The rn from the ccu called and stated that the pump was in 1:4.The css asked if the cardiologist replaced the balloon catheter.The rn stated that the cardiologist just had them leave the pump in 1:4 since it was not alarming.Per the rn "the cardiologist told them if the pt survived the night he would take him back to the cath lab in the morning." the css explained that the yellow numbers are the patient's unassisted pressure.The rn asked what pressure she should use to titrate the pressors.The css explained since three of his beats were unassisted and only one was assisted, they should monitor and use the unassisted pressures.At present the unassisted map is ranging from 60's to 70 mmhg.The rn had no other questions at this time.
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Manufacturer Narrative
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Qn#(b)(4).Device evaluation: returned for evaluation was a 40cc 8.0fr fos (fiberoptix sensor) iab.Upon return the short driveline tubing was connected to a 40cc inflation driveline tubing.The iab hemostasis cuff was connected to the cathgard.The teflon sheath was approximately 42.6cm from the iab distal tip and was connected to the iab hemostasis cuff.The iab assembly had the pressure line connected to the iab luer.Some fluid was observed within the pressure line.The one-way valve was connected to the short driveline tubing.Some spots of blood were observed on the exterior of the bifurcate, cathgard / hemostasis cuff, sheath hub and on the interior of the bladder and sheath.The bladder was loosely wrapped.Bends were noted at approximately 40cm and 73cm from the iab distal tip.A knot was observed in the fos yellow jacket cabling from 86.5cm to 90cm from the blue slide housing.The fos connector and cal key were examined.The fos connector was properly seated in the housing and both retaining tabs were intact.The center post of the fos was centered.See other remarks section for continuation.Other remarks: the blue slide housing was examined and no abnormalities were noted.The cal key was intact.The one-way valve was tested and passed.A vacuum was pulled on the one-way valve and it held for at least 1 minute and then 30 seconds five separate times.The cal key and fos were connected to the iabp.The cal key was recognized.The fos was connected and the iabp zeroed the iab.The pump status displayed "ok" indicating the fiber was fully intact.The iab was connected to an iabp with a lab-inventory 40cc driveline tubing.The fos was zeroed.The iab was inserted into the "t" tube and 100mmhg backpressure was applied.The iab was pumped for a minimum of five minutes.There were no alarms triggered.The bladder inflated and deflated with each beat, but it was observed that the bladder was not fully inflating.The balloon pressure waveform (bpw) was normal and the mean arterial pressure (map) was reading correct when using the fos.When using the transducer, the mean arterial pressure (map) was reading incorrect and appeared dampened.The iab was submerged in water and leak tested.The unit passed the leak test.No holes or leaks were noted on the bladder membrane.The bladder membrane did not fully inflate during the leak test and the distal area of the bladder membrane appeared twisted during inflation.Upon attempting to unravel the twisted portion of the bladder membrane, the area of the bladder membrane near the outer lumen began to twist.After completing the remaining tests, the bladder was cut at the distal tip to further investigate the flex tip assembly and center lumen.Upon further inspection, the flex tip assembly was found with the bond broken to the central lumen.Under microscopic investigation, the broken bond was confirmed between the flex tip assembly and central lumen.A lab-inventory 0.025 inch spring wire guide (swg) was back loaded through the iab distal tip.Resistance was noted at approximately 41cm and 73.4cm from the iab distal tip.The swg was able to advance through the central lumen.No blood or debris was noted.The swg was front loaded through the iab luer.Resistance was noted at approximately 9.2cm and 40.5cm from the iab luer.The swg was able to advance through the central lumen.No blood or debris was noted.The catheter was aspirated and flushed using a 60cc lab-inventory syringe.No abnormalities or d ebris were noted.A device history record review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of iab kinked is not confirmed; however, the reported "dampened ap pressure waveform" is confirmed through the transducer.The bends noted on the central lumen or the twisted bladder may have caused the dampened transducer signal.Engineering was notified of the twisted bladder/broken bond issue, and it will be monitored for any developing trends.The root cause of the bend to the central lumen is undetermined.Nc60033493 has been initiated to investigate cause of the issue.
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Event Description
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It was reported that the respiratory therapist (rt) from the cardiac care unit (ccu) was calling because they were getting alarms on the pump and no arterial pressure (ap) signal.An intra-aortic balloon (iab) was inserted via the patient's (pt) right femoral artery while in the cath lab.The pt was ventilated, sedated, in sinus tachycardia, and levophed and dopamine infusing.There were alarms on the pump when the pt returned to the ccu; pt had begun trashing.The pt was taken back to the cath lab because of the alarms.The position of the catheter was fine.They returned to the unit and continued to have issues with the helium alarms and ap waveform.The pt was switched to a second pump while in the cath lab.The pump was using the central lumen of the catheter and the arterial line was dampened.The css had the rt aspirate and flush the line.The rt said it was sluggish.The css asked the rt to put some traction on the catheter and hyperextend the hip and the arterial line improved.The css and rt discussed that the fiberoptix sensor (fos) status was pl (fos is measuring outside of pressure range).The icon was white (fiberoptix iab cal value manually adjusted).The rt did not have an ap waveform on the screen.The css had him connect the fiberoptic and the css could hear the audible tone.When the rt had the fiberoptic and cal key connected, the icon turned green (fiberoptix iab zero'd prior to insertion), but there was no waveform on the screen.The fos code was pl (fos is measuring outside of pressure range), and eo (excessive offset: zeroing procedure resulted in a large difference from factory set calibration).The css had the rt try to calibrate the fiberoptic, but the pump gave a message unable to calibrate.The css told the rt to use the central lumen of the balloon for the timing on the first pump.The rt stated message "no ap signal available" was on the pump.The central lumen waveform was much dampened.The css had the rt aspirate, flush, put traction on the catheter and reposition the pt.This did not improve the waveform.They were currently placing a radial line in pt.The css had the rt connect the radial line to the pump for timing.The pump was pumping and not alarming.The rt sent a picture which showed late deflation.The balloon pressure waveform (bpw) was not getting back to zero, but not alarming.The css had the rt decrease the volume in the balloon with no change; the bpw was not getting back to zero.When in 1:2 the bpw was not getting back to zero.The css had the rt go to operator mode and adjust the timing so that they should have late inflation and early deflation.The bpw still was not getting back to zero.The intra-aortic balloon pump (iabp) also was not alarming "possible helium loss." the css had the rt decrease the volume to 35 cc with no change.The css had the rt go to 1:4.The bpw was slow, but did get back to zero.The deflation timing looked late even in 1:4.The css had the rt power the pump off and back on with no change.The css had the rt connect the pt to a third pump and there was no change.We were about to change to a fourth pump when the third pump began alarming "possible helium loss".The third pump was in operator mode with inflation set at 50% and deflation set at 75% and balloon volume at 35 cc.The css had the rt flush the radial line and the arterial waveform stayed the same.The css had rt check to make sure there was no blood in the gas driveline tubing and the rt said there was none.At this time it was realized that this had to be a problem with the catheter since the central lumen was not working, the fiberoptic was not working, and we could not get the bpw to come back to baseline.The css recommended they change the catheter.It appeared to the css that the pump could not get the helium back out in time and was causing the late deflation appearance on the arterial waveform.The rt agreed with the css and was going to discuss with the physician.A second call was received at 7:27am mt.The rn from the ccu called and stated that the pump was in 1:4.The css asked if the cardiologist replaced the balloon catheter.The rn stated that the cardiologist just had them leave the pump in 1:4 since it was not alarming.Per the rn "the cardiologist told them if the pt survived the night he would take him back to the cath lab in the morning." the css explained that the yellow numbers are the patient's unassisted pressure.The rn asked what pressure she should use to titrate the pressors.The css explained since three of his beats were unassisted and only one was assisted, they should monitor and use the unassisted pressures.At present the unassisted map is ranging from 60's to 70 mmhg.The rn had no other questions at this time.
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