MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number HLS CANNULA + PIK

Device Problem No Flow (2991)

Patient Problems Air Embolism (1697); Death (1802); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2021

Event Type  Death  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.Product was requested for further investigation on 2021-22-02.

Event Description

It was reported from a customer from (b)(6), a few minutes after the end of manipulation with the patient, the ecmo system suddenly stop and air was detected in the jugular in-flow cannula.Initiated cpr, cyanosis of the head, probably air embolism.With cpr running, first attempt to bleed the system, then convert to va-ecmo.Cpr lasted for about 60 minutes, then temporarily sufficient perfusion pressure at a flow to ecmo of 4.5 l / min.Transiently improved oxygenation, but severe disruption of the homeostasis.Subsequently exitus letalis.The patient covid positive.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that air entered the system during vv ecmo and ecmo stops accordingly.Meanwhile, air was observed in the pal 1923 cannula in the jugular vein.The product was investigated in the laboratory of manufacturer on 2021-04-16.The visual inspection showed that there were few scratches on connector of the cannula.The tightness test was performed.Since no air escaping from the cannula could be observed even after more than 5 seconds at 1.5 bar, the cannula could be described as tight.The results of the investigation in the laboratory showed that there are no cracks at the connector housing or other defects which might caused an air intake by the cannula.The scratches on the cannula body are at the designated clamping area for the surgeon.The applied pressure in the investigation lab with the value of 1,5 bar shows definitely that the housing was free of leakage.Based on this, no product related problem could be confirmed.Medical review was performed on 2021-04-21 by medical affairs based on the received information from the customer and sample investigation report.The investigation laboratory showed clearly that the connector housing has no leaking defect, therefore the failure of air intake is assumed to be caused by a wrong user interaction.As the product had no defects, a definitive root cause of air entrainment into the be-pal hls 1923 cannot be directly determined, established, or attributed to the product.However, the following may be reasonable root causes: the use of an arterial cannula in a venous return position may increase the suction risk.A suction risk may manifest as cavitation, damage to surrounding vascular structures, and/or the aspiration of air from/through other structures (e.G.Cannula purse strings).Additionally, if a low volume status were introduced, coupled with the use of an arterial cannula placed in the venous return position, excess suction (observed as negative pressure) may be applied to the vascular structure(s) of the venous system and provoke air embolisms.The construction of a cannula intended for venous application versus arterial application may also be a factor.The lower number and position of drain holes in an arterial cannula (when compared venous cannula designed to be used in a venous position), may exacerbate the suction risk when used in combination with excessive negative pressure.The use of tracheostomy may introduce the ingress of air into a cannula placed in the venous system.The hls cannula ifu mentions the following: during tracheotomy there is a risk of vascular injury (inferior thyroid vein).If you perform a tracheotomy whilst the patient is connected to an extracorporeal life support system, vascular damage in the area of the catheter of the extracorporeal life support can result in bleeding and possibly the ingress of air into the catheter which, in turn, result in an air embolism in the patient.It is also possible that during manipulation the cannula may have caused a perforation or a distortion in the surrounding tissues, allowing air to be drawn air into the cannula.Last, the report mentioned that the rpms of the centrifugal pump were 5000 at the time of the event this level of rpms may have exacerbated aspiration risk by the application of excessive negative pressure to the cannula and venous structures.Additionally, this may have created an environment where air was drawn into the cannula because of physical manipulation of the cannula (or patient) or through physical distortion of the surrounding tissues/structures.Given the evidence that is currently available, the entrainment of air into the cannula (as explained in the complaint) cannot be directly attributed to the product itself.With reference to the risk assessment hls cannulae (long-term), dms-no.1992719 / version 4b chapter h2.4.32, f1.2.1 the most probable root cause is associated with the user error due to using the arterial cannula for drainage.Based on the investigation so far the reported failure could not be confirmed.Device history record was reviewed on 2021-02-16.There were no references found, which are indicating a non-conformance of the product in question.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is 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.

Event Description

Complaint#: (b)(4).

Manufacturer Narrative

It was reported that air entered the system during vv ecmo and ecmo stops accordingly.Meanwhile, air was observed in the pal 1923 cannula in the jugular vein.The product was investigated in the laboratory of manufacturer on 2021-04-16.The visual inspection showed that there were few scratches on connector of the cannula.The tightness test was performed.Since no air escaping from the cannula could be observed even after more than 5 seconds at 1.5 bar, the cannula could be described as tight.The results of the investigation in the laboratory showed that there are no cracks at the connector housing or other defects which might caused an air intake by the cannula.The scratches on the cannula body are at the designated clamping area for the surgeon.The applied pressure in the investigation lab with the value of 1,5 bar shows definitely that the housing was free of leakage.Based on this, no product related problem could be confirmed.Medical review was performed on 2021-04-21 by medical affairs based on the received information from the customer and sample investigation report.The investigation laboratory showed clearly that the connector housing has no leaking defect, therefore the failure of air intake is assumed to be caused by a wrong user interaction.As the product had no defects, a definitive root cause of air entrainment into the be-pal hls 1923 cannot be directly determined, established, or attributed to the product.However, the following may be reasonable root causes: ¿ the use of an arterial cannula in a venous return position may increase the suction risk.A suction risk may manifest as cavitation, damage to surrounding vascular structures, and/or the aspiration of air from/through other structures (e.G.Cannula purse strings).Additionally, if a low volume status were introduced, coupled with the use of an arterial cannula placed in the venous return position, excess suction (observed as negative pressure) may be applied to the vascular structure(s) of the venous system and provoke air embolisms.The construction of a cannula intended for venous application versus arterial application may also be a factor.The lower number and position of drain holes in an arterial cannula (when compared venous cannula designed to be used in a venous position), may exacerbate the suction risk when used in combination with excessive negative pressure.¿ the use of tracheostomy may introduce the ingress of air into a cannula placed in the venous system.The hls cannula ifu mentions the following: during tracheotomy there is a risk of vascular injury (inferior thyroid vein).If you perform a tracheotomy whilst the patient is connected to an extracorporeal life support system, vascular damage in the area of the catheter of the extracorporeal life support can result in bleeding and possibly the ingress of air into the catheter which, in turn, result in an air embolism in the patient.¿ it is also possible that during manipulation the cannula may have caused a perforation or a distortion in the surrounding tissues, allowing air to be drawn air into the cannula.¿ last, the report mentioned that the rpms of the centrifugal pump were 5000 at the time of the event this level of rpms may have exacerbated aspiration risk by the application of excessive negative pressure to the cannula and venous structures.Additionally, this may have created an environment where air was drawn into the cannula because of physical manipulation of the cannula (or patient) or through physical distortion of the surrounding tissues/structures.Given the evidence that is currently available, the entrainment of air into the cannula (as explained in the complaint) cannot be directly attributed to the product itself.With reference to the risk assessment hls cannulae (long-term), dms-no.1992719 / version 4b chapter h2.4.32, f1.2.1 the most probable root cause is associated with the user error due to using the arterial cannula for drainage.Based on the investigation so far the reported failure could not be confirmed.Device history record was reviewed on 2021-02-16.There were no references found, which are indicating a non-conformance of the product in question.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is 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.

Event Description

Complaint # (b)(4).

• Brand Name: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11371739
• MDR Text Key: 233248299
• Report Number: 8010762-2021-00123
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: HLS CANNULA + PIK
• Device Catalogue Number: 701047287
• Device Lot Number: 92257553
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 05/10/2021; 05/10/2021
• Supplement Dates FDA Received: 05/10/2021; 05/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death