MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BO-HQV 10600

Device Problem Output Problem (3005)

Patient Problem Hypoxia (1918)

Event Date 02/06/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after 35 minutes of cec there was an oxygen problem.Customer increased fio2 from 75% to 100% however pao2 was not increased between 60s and 70s.Customer thought that it could be arrival problem, and used one more bottle of oxygen and after that pao2 was still in 60s.Customer prepared another pump to continue the intervention.The failure was detected while using the product on the patient.Hypoxia occurred during the treatment.Complaint #(b)(4).

Manufacturer Narrative

A follow up medwatch will be submitted when further information becomes available.The correction e-mdr follow up was required.Type of reportable event is corrected as serious injury, device evaluated by mfg in part h is changed to no and code for device not evaluated description is provided.Usage of device is updated as initial use.

Event Description

It was reported that after 35 minutes of cec there was an oxygen problem.Customer increased fio2 from 75% to 100% however pao2 was not increased between 60s and 70s.Customer thought that it could be arrival problem, and used one more bottle of oxygen and after that pao2 was still in 60s.Customer prepared another pump to continue the intervention.The failure was detected while using the product on the patient.Hypoxia occurred during the treatment.Complaint # (b)(4).

Manufacturer Narrative

It was reported that after 35 minutes of cec there was an oxygen problem.Customer increased fio2 from 75% to 100% however pao2 was not increased between 60s and 70s.Customer thought that it could be arrival problem, and used one more bottle of oxygen and after that pao2 was still in 60s.Customer prepared another pump to continue the intervention.The failure was detected while using the product on the patient.Hypoxia occurred during the treatment.The getinge laboratory investigation has been completed on 2022-04-14.Visual control was performed and some clots were found at arterial filter of oxygenator.Leakage was detected at gas outlet of oxygenator.Since the leak was not initially reported by customer to mcp the leak on the blood side detected in the laboratory is not within the scope of the examination result.It could conclude that there was a disruption in the blood flow within the module, which led to a reduction in the performance of the oxygenator.Reduced oxygenation performance due to clot formation in the oxygenator was found as a reason of reported failure.Based on the test results, failure could be confirmed.The production records of the affected oxygenator were reviewed on 2022-03-28.Following tests are performed according to 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.The production history record (dhr) of the affected bo-hqv 10600#pack complete with lot#3000204176 was reviewed on 2022-03-28.According to the dhr results, the product bo-hqv 10600#pack complete passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Medical review was performed on 2022-05-06 by getinge medical affairs.According to the review conclusion, the most likely explanation for the continuously reduced function of the oxygenator is clotting inside the membrane and lower than necessary blood flow.The actual blood flow deviates significantly from the calculated target flow.However, it is not clear from the provided data if it was possible to increase the blood flow to reach target flow, and if such an increase in blood flow would have resulted in an increase in pao2 and normal oxygen delivery.Also, the clotting within the membrane may have contributed by the overall lower than recommended act values.Other parameters that might allow a better determination, unfortunately, were not provided.Insufficient anticoagulation measurement combined with missing delta pressure measurement likely allowed a reduced function of the oxygenator further leading to a late change out of the product.The probable root causes have been found as: - clotting in the oxygenator.- lower than necessary blood flow.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

(b)(4).

• Brand Name: TUBING SETS
• Type of Device: TUBING, PUMP, 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: 13511902
• MDR Text Key: 285453245
• Report Number: 8010762-2022-00049
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: BO-HQV 10600
• Device Catalogue Number: 701035335
• Device Lot Number: 3000204176
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention