MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-I SMALL ADULT/ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 71000

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

The product was requested for return but not yet received.The investigation of the manufacturer is ongoing.(b)(4).

Event Description

It was reported that the oxygenator has had a high venous pressure of 650 mmhg during patient treatment.The oxygenator was used for approx.100 minutes.The product was replaced during hlm perfusion due to the excessive pressures.No harm was reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the oxygenator had a high pressure of 650 mmhg pre oxygenator.Complete hlm was exchanged.A perfusion report was provided.The returned product was investigated at the laboratory of the manufacturer.During visual inspection a heavy clotted arterial filter and clotting in the area of the de-airing membrane at venous side was detected.During the flow test no significant pressure increase could be confirmed.Neither on the venous side nor on the arterial side.Thus the reported failure"high pressure of 650 mmhg" was not reproducible during technical investigation.The production records of the affected oxygenator (batch 3000242418, 3000242475) were reviewed.Following tests are performed as a 100 % inspection: ¿ leak test after welding ¿ pressure test heat exchanger ¿ leak test water side ¿ leak and flow test gas side ¿ pressure test blood side ¿ coating test according to the final test results, the oxygenator with the serial# (b)(6) passed the test as per specifications.Production related influences can be excluded.Based on the investigation results a most probable cause of the reported failure could be clotting within the arterial filter.Thus the reported failure "high pressure of 650 mmhg" could be confirmed but was not contributed by or associated with a product related malfunction.Furthermore a medical assessment of the provided event information and laboratory investigation results was performed with the following outcome: based on a careful review of the available information received in the electronic clinical record, the customer product complaint report, the limited correspondence describing the event, and the pems investigation report, four possible root causes seem plausible.It is notable that the oxygenator performance and case proceeded unremarkably from 0923 hours until 1033 hours.The circuit was primed and a pre-functional check was completed.There were no reported issues with oxygen transfer and high-pressure excursion until the acute elevation of pre-membrane pressures on, or about 1033 hours.The four proposed possible root causes based on the available information include: - a technical failure of the pressure transducer resulting in a false positive high-pressure measurement.- an outflow obstruction of the arterial cannulae or arterial line.- competitive flow associated with the implantation of the left ventricular assist (the heart mate iii).- an oxygenator clot/thrombosis.Each of the plausible root causes will be briefly commented on separately.A possible root cause for the reported event could be a pressure transducer failure that resulted in a significantly false positive increase in arterial line pressure.Figure 7 is an excerpt from the electronic record that is interpreted as a normal pressure trend until the actual event.The pressure increase is very rapid and it suggests an urgent change out of the hardware and disposable were deemed necessary, possibly because of a pump stop, or a valid concern of tubing disconnect/rupture.A second possible cause may have been associated with implantation and manipulation of the lvad.There may have been an acute obstruction of the inflow arterial cannulae.Alternatively, competitive/opposing flow between the lvad and the aortic cannulae may have generated a significant increase in afterload in the aortic root.The follow-up correspondence and protocol did not provide any correlation between the event and the surgical interventions that could be associated with the reported event however.A review of the clinical record indicates the patient required significant heparin anti-coagulation (@600 units/kg).Systemic heparinization typically requires an empiric dosing of 300-400 units/kg to achieve and maintain the minimum activated clotting time of 480 seconds as per getinge recommendations in the ifu (figure 4) and in the literature (maquet cardiopulmonary gmbh, 2021), (durrani, ali, & jafri, 2018).Anticoagulant management, assessment and protocols are the responsibility of the attending physician.Figure 3 and figure 4 represent the extracted data from the clinical protocol.At 0934 hours, the act dropped to 386 seconds.This value in of itself does not suggest sub-therapeutic anti-coagulation actually occurred; rather it suggests possible ¿heparin resistance¿ that may have been a precursor to thrombin generation and subsequent clot generation in the oxygenator.The pre-operative state of the patient was not described but clearly, this was a complex presentation with cabg, asd and lvad implant.The sequence of events and surgical intervention were not described but it appears the high pressures occurred about 30 minutes following cross clamp removal at 1003 hours.Until the high pressure occurred, the oxygenator appears to have been functioning within specification.There may have been pre-operative and intraoperative factors that were not included in the correspondence that contributed to a ¿hyper-coagulable state¿ [(at iii deficiency-(congenital or acquired), thrombocytosis, age, increased factor viii and fibrinogen levels, disseminated intravascular coagulation, liver disease, or acute thrombosis].The lvad implantation (heart mate iii) may have also contributed to a thrombotic state given the additional foreign surface and contact activation that occurs during implantation and thereafter (loyoga-rendon, kazui, & acharya, 2021).No clot, fibrin strands or platelet consumption or aggregation was reported in the correspondence.The clinical protocol indicated there was an acute increase in pre-membrane pressures.Thrombus deposition and transmembrane pressure usually increase gradually over time in a micro-porous membrane.There were no blood gases or in line measurements that could be associated with a degradation in oxygenator performance that would support this mechanism as a root cause.A large thrombus from the surgical field or activated blood from the surgical field could be the nidus for clot formation, followed by an acute increase in pre-membrane pressure.The pems report identified significant clot accumulation in the arterial filter and small amounts of clot in the ventilation membrane.These findings strongly support acute thrombosis of the oxygenator due to one or more of the above mechanisms described above.The primary root cause may have been triggered by patient related factors, anti-coagulant management, or by example exposure to activated /un-heparinized blood from the surgical field based on the latent occurrence.Ultimately, it appears the event was expeditiously managed by the surgical and perfusion team.There was no reported harm and no evidence of patient compromise based on the in-line blood gas metrics that were reported in the second bypass phase.The transition time between hardware and disposables appears to be very brief (< 2.5 minutes).It is not clear whether the patient had lvad support and native pulmonary perfusion during this transition interval.Based on the available information it is not possible to attribute this event to a device malfunction or underperformance.There is no evidence to support a use error as a cause.This event was not associated with patient harm.The occurrence rate was calculated for the reported issue 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 id: (b)(4).

• Brand Name: QUADROX-I SMALL ADULT/ADULT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15852693
• MDR Text Key: 304202475
• Report Number: 8010762-2022-00465
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HMO 71000
• Device Catalogue Number: 701067821
• Device Lot Number: 3000242418
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 107 KG