MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number QUADROX ID SMALL ADULT/ADULT-

Device Problem Infusion or Flow Problem (2964)

Patient Problems Hypoxia (1918); Sepsis (2067); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2023

Event Type  Injury  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the clinical stuff hat to do an emergency circuit change out of the quadrox two times.The circuit was only 26 hours old.The delta pressures were fine.The patient was desaturating and the post oxy was po2 : 242 pre change.The patient was anticoagulated.The aptt was therapeutic throughout.The pumps flow were running at 6.5l/min prior to the circuit to maintain some level of oxygenation and are currently sitting at 5.8l/min.Pint have been between 240-280mmhg dependent on the flow.They swapped the oxy blender (sgb) too in an attempt to trouble shoot.The failure occurred during treatment.No harm to any person has been reported.Complaint id# (b)(4).

Event Description

Complaint id (b)(4).

Manufacturer Narrative

Both affected products were investigated by getinge laboratory on 2023-08-10 with following conclusion: during visual inspection there was on one hls set a kink in the tubing on the blood outlet connector and both lugs were damaged, which was not reported by the customer and is not related to the reported failure.The pressure, tightness and leakage test were passed.No technical root cause could be determined, as no failure could be confirmed.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

New information was received on 2023-08-21 that the second hls set was exchanged due to worsening hypoxia.The flow increased, but became more and more profound.New source of sepsis driving increased demand.A third hls set exchange was performed due to dramatic clinical hypoxia.A follow-up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

New information was received, that not two quadrox were affected.The two affected products are hls sets.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint id# (b)(4).

Event Description

Complaint id (b)(4).

Manufacturer Narrative

It was reported that the clinical stuff hat to do an emergency circuit change out.The circuit was only 26 hours old.The delta pressures were fine.The patient was desaturating and the post oxy was po2 : 242 pre change.The patient was anticoagulated.The aptt was therapeutic throughout.The pumps flow were running at 6.5l/min prior to the circuit to maintain some level of oxygenation and are currently sitting at 5.8l/min.Pint have been sitting between 240-280mmhg dependent on flows.The second hls set was exchanged due to worsening hypoxia.The flow increased, but became more and more profound.New source of sepsis driving increased demand.A third hls set exchange was performed due to dramatic clinical hypoxia.Both affected products were investigated by getinge laboratory on 2023-08-10 with following conclusion: during visual inspection there was on one hls set a kink in the tubing on the blood outlet connector and both lugs were damaged, which was not reported by the customer and is not related to the reported failure.The pressure, tightness and leakage test were passed.No technical root cause could be determined, as no failure could be confirmed.A medical assessment was performed by getinge medical affairs on 2023-08-25 with following conclusion: ¿the picture that develops from the confluence of the complaint narrative, lce investigation, and customer questionnaire appear to suggest a root cause outside malperformance or malfunction of the product.It is possible that clotting inside the hls set advanced, or subclinical clotting, may have contributed to the po2s observed by the customer by reducing the amount of available membrane area.Doymaz1 suggested that an recommended level for aptt is 1.5x to 2.5x baseline, which suggests a range of 60 ¿ 80 seconds.The complaint narrative stated that the aptt was maintained in a range of 40 ¿ 56 seconds.According to roundtree, normal aptt/ptt values can vary between laboratories, but 25 to 35 seconds is considered a normal range without anticoagulation.Active clotting is indicated by a d-dimer value > 0.503,4 a d-dimer value of 22.86 was reported in the customer questionnaire (table 3).This may be suggestive of circuit thrombosis or subclinical clotting.Barring a high o2 extraction from a patient, the po2s reported in the customer seem to fall with the expected oxygen transfer rate of a functional membrane.However, because venous oxygen saturations were not provided by the customer, an oxygen transfer calculation cannot be performed to provide confirmation of this assumption.As a note, the assumption is based on the oxygen transfer curve provided in the product ifu (instructions for use).A post-membrane oxygenation (arterial) of 99% is suggestive of full saturation of available hemoglobin.The event description states that sepsis was a source of increased oxygen demand, which required higher flows to address accelerated oxygen extraction.This suggestion confirms the current mindset on sepsis and oxygen extraction.No details were shared regarding the outcome of the patient in this complaint.The complaint narrative explains that bilvalirudin was used as an anticoagulant.However, no details are given in terms of why bilvarirudin was chosen opposed to heparin.It may be assumed that the concern was heparin induced thrombocytopenia (hit), which may explain subclinical clotting and thrombocytopenia, but no details were provided regarding the choice of anticoagulants.Finally, it cannot be confirmed that the root cause of the perceived hypoxia was product related.Further, the result of the lce investigation suggests that no product related root cause (i.E., either diminution in performance or malfunction of the product) could be identified.As mentioned in the leading sentence, the root cause of the observed event was likely unrelated to (outside of) the product.¿ the production records of the affected products were reviewed on 2023-08-28.According to the final test results, both moduls passed the tests as per specifications.Production related influences are unlikely.Based on the results the reported failure "desaturation of the patient" could not be confirmed and was not product related.The customer will be informed about the results by the getinge sales and service unit.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.

• Brand Name: OXYGENATOR
• 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: 17080446
• MDR Text Key: 316871686
• Report Number: 8010762-2023-00270
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2023

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 Model Number: QUADROX ID SMALL ADULT/ADULT-
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 07/09/2023; 08/10/2023; 08/21/2023; 08/25/2023
• Supplement Dates FDA Received: 07/20/2023; 08/11/2023; 08/21/2023; 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male