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MAQUET CARDIOPULMONARY GMBH QUADROX-ID SMALL ADULT/ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS
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| Model Number HMOD 70000-USA |
| Device Problem
Gas/Air Leak (2946)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 11/04/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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The investigation of the manufacturer is ongoing.
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Event Description
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It was reported that on thursday morning, (b)(6) 2021, the customer was attempting to initiate vv ecmo (veno venous extra corporal membrane oxygenation) with an centrimag circuit that had a mcp quadrox oxygenator.The customer initially had the rpm's (rotations per minute) set at 1000.When the customer took both clamps off the venous/arterial tubing, he noticed the post-oxygenator face of the oxygenator began to fill with air from top down.The customer clamped the circuit, attached the quick prime line, and pulled the air off the top port with a syringe.He turned the rpm's up to 2000 and tried initiating ecmo again, in which the same thing happened.He again clamped the tubing lines and reprimed the oxygenator.After discussing/troubleshooting with the fellow and calling his back up perfusionist over the phone, he checked all connections (which were all tight), made sure the circuit was built correctly (which it was), and tried to initiate once more.Again, the post-oxy filled with air.At this point, the back up perfusionist was on his way in to help.The patient was stable enough that we were all willing to wait for him to troubleshoot the circuit before we used a different one.The back up perfusionist decided they should try to turn up the rpm's to 3000 and initiate ecmo.The circuit was flowing at about 1.5 lpm and 1300 rpm.There was good color change in the lines and the patient's spo2 was 100%.The abg from the patient's femoral line also showed good oxygenation with the circuit.However, about every 30 seconds, more air would fill on the post-oxy side and they had to continually pull it out with a syringe.After about a half hour of this, the decision was made to change the entire circuit out and he placed the patient on a cardiohelp circuit with no issues after that.Complaint id: (b)(4).
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Manufacturer Narrative
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It was reported that on thursday morning, (b)(6) 2021, the customer was attempting to initiate vv ecmo (veno venous extra corporal membrane oxygenation) with an centrimag circuit that had a mcp quadrox oxygenator.The customer initially had the rpm's (rotations per minute) set at 1000.When the customer took both clamps off the venous/arterial tubing, he noticed the post-oxygenator face of the oxygenator began to fill with air from top down.The customer clamped the circuit, attached the quick prime line, and pulled the air off the top port with a syringe.He turned the rpm's up to 2000 and tried initiating ecmo again, in which the same thing happened.He again clamped the tubing lines and reprimed the oxygenator.After discussing/troubleshooting with the fellow and calling his back up perfusionist over the phone, he checked all connections (which were all tight), made sure the circuit was built correctly (which it was), and tried to initiate once more.Again, the post-oxy filled with air.At this point, the back up perfusionist was on his way in to help.The patient was stable enough that we were all willing to wait for him to troubleshoot the circuit before we used a different one.The back up perfusionist decided they should try to turn up the rpm's to 3000 and initiate ecmo.The circuit was flowing at about 1.5 lpm and 1300 rpm.There was good color change in the lines and the patient's spo2 was 100%.The abg from the patient's femoral line also showed good oxygenation with the circuit.However, about every 30 seconds, more air would fill on the post-oxy side and they had to continually pull it out with a syringe.After about a half hour of this, the decision was made to change the entire circuit out and he placed the patient on a cardiohelp circuit with no issues after that.The affected product was technically investigated at the laboratory of the manufacturer.Priming of the system according to the ifu was uneventful.Upon that a tightness test of 360 minutes duration was performed with no abnormalities detected.Additionaly a tightness test of the water side was performed with no abnormalities detected.The product was operating within specifications and the reported failure "face began to fill with air" was not reproducible.Thus it was not possible to determined the exact root cause of the reported event.The reported failure was not confirmed during product investigation.However, the investigation results and event information was reviewed by our medical experts and the following was concluded in regards to a most probable cause of the reported event: based on the complaint review and correspondence the following are not likely to have caused air entrainment in this particular case.- air entrainment from the venous side of the circuit.- an excessive sweep gas pressure that exceeded the blood side pressure in the membrane.The report description provided by the end users does not support these variables as a root cause although these cannot be completely ruled out.Negative pressure on the blood side of the membrane is a possible variable but not likely based on the vv ecmo application.Two additional variables warrant discussion.According to the instructions for use the yellow protective cap must be in place during operation.Air entrainment may result pre-oxygenator via the de-airing membrane and accumulate post oxygenator as described in the complaint.The yellow cap was removed from the de-airing membrane during operation and may have been contributory.The position of the quadrox-id relative to the patient height is an important consideration.According to the instructions for use the oxygenator must be positioned below the patient or air entrainment is possible.Given the ecls system used was not described, the reviewer cannot conclude whether oxygenator position was a contributory variable.The accumulation of air as described may have resulted from one or more of the above variables.A use error has been identified with respect the necessary replacement of the yellow cap following the priming sequence and during application.It should be considered one of the contributing variables in the constellation of possible causes in isolation or in combination that have been presented in this review.Preventively, a medical affairs expert of maquet cardiopulmonary will follow up with the customer via the ssu (sales and service unit) in regards to the investigation results.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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Event Description
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Complaint id: (b)(4).
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