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

Model Number HMO 70000

Device Problems Partial Blockage (1065); Increase in Pressure (1491)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that the delta p of the oxygenator increased to >200 mm hg after 4 minutes of support of a patient requiring resuscitation.Product was exchanged during patient treatment.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a patient needed resuscitation during initiation of operation.17 minutes later the patient was connected to the quadrox.The quadrox becomes impermeable after four minutes of support.The delta pressure increased to over 200mmhg and clotting on the inlet side of the oxygenator was discovered.Therefore the quadrox was exchanged during treatment.The affected quadrox was investigated by getinge laboratory on (b)(6) 2023.There were no clots observed.Additionally no abnormalities or damages were found during visual inspection due to clotting.Further a medical assessment was performed by getinge medical affairs on (b)(6) 2023 with following conclusion: "based on the limited information provided a definitive root cause cannot be established.The oxygenator was primed and presumably, a pre-functional check was completed prior to application.There were no reports of damage to the disposable or to the packaging material prior to assembly and application.Functional gas exchange (o2 delivery/ co2 removal) was not reported but it appears the circuit priming and preparation were uneventful.Gas transfer was not reported to be impaired.The event is isolated to an ¿early¿ acute increase in transmembrane pressures.Systemic heparin dosing was reported.It appears systemic heparinization was achieved based on the clinical report provided.Act levels pre-bypass (13:12 hours) and on bypass (13:20 hours) were 467 second and 509 seconds respectively.That said there was significant instability pre-bypass that included resuscitation, emergent cannulation and initiation of cpb.The scenario is challenging to evaluate given the patient was hemodynamically compromised during heparin dosing.It is plausible the urgency of cpb initiation may not have allowed adequate heparin circulation to achieve a systemic effect.Alternatively, non-heparinized surgical suction may have been recovered into the extra-corporeal circuit setting the circumstances for acute oxygenator thrombosis.Either ¿possible¿ scenario could explain the acute increase in transmembrane pressure.Although the investigation report has not been completed, at this stage there is no indication the observed event was related to a device malfunction/mal-performance related manufacturing.Rather the event appears to be associated with the urgent/emergent clinical sequence of events, and the need to initiate bypass as reported in the complaint report and electronic record.A third possibility that was considered was atiii deficiency.The clinical record indicates atiii concentrate 1000 units was administered at 13:22 hours prior to the second bypass run.According to the correspondence, there was no patient harm.The clinical team identified the acute increase in transmembrane pressure, and efficiently changed out the extracorporeal circuit without incident (discontinued and resumed bypass between 13:24 hours and 13:27 hours).".The production records of the affected quadrox were reviewed on (b)(6) 2023 for the reported failure.According to the final test results, the quadrox passed the test as per specifications.Production related influences are unlikely.Based on the results the reported failure "clots on the inlet side of oxygenator" could not be confirmed.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: 16527543
• MDR Text Key: 311210082
• Report Number: 8010762-2023-00131
• 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: Other,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2024
• Device Model Number: HMO 70000
• Device Catalogue Number: 701067818
• Device Lot Number: 3000233352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/07/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female