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

Model Number HLS SET

Device Problem Increase in Pressure (1491)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that the delta pressure was increased during use.The set was replaced with no harm to the patient.Complaint id#(b)(4).

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that the delta pressure was increased during use.The set was replaced with no harm to the patient.The patient was infected with covid-19.The affected hls module with lot#3000164491 was investigated in the getinge laboratory on 2022-04-05 with the following results.During the investigation no abnormalities were detected.Further no leakage or functional issues of the pump could be confirmed.The investigated hls module worked according to its specifications.The patient was infected with covid-19.As stated by the getinge medical affairs team and in reference to the literature [1] covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.The increased risk of thrombosis and coagulopathy in ecmo patients is a result of a combination of processes driven by the disease occurring in synergy with the effect of the extracorporeal circuit on the coagulation system.[1] with reference to the risk assessment hls set advanced 5.0 / hls set advanced 7.0, dms#1468452, v26 and in consultation with the manager medical affairs the following events can contribute to the reported failure: - air remains in or enters the circuit; - hemostasis; - air or blood remains in luer lock access port; - too low anticoagulation; - too low at level, effect of heparin is too limited; - protamine sulfate enters the hls set; - administration of substitution of congealable substance such as plateles; - (consumption) coagulopathy; - thrombozytopenia.The production records of the affected hls module (batch #3000164491 ) were reviewed on 2022-04-06.Following steps are performed according to the bop with a 100 % inspection: following tests are performed according to the bop as a 100 % inspection: * pressure test heat exchanger; * leak test water/gas side; * pressure test blood side; * final functional test.According to the final test results, the hls module with the serial#(b)(6) passed the tests as per specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.Based on the investigation results the reported failure "delta pressure increased" could be confirmed, but not product related malfunction.The occurrence rate was calculated for the reported failure 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.Reference: [1] yusuff h, zochios v, brodie d."thrombosis and coagulopathy in covid-19 patients requiring extracorporeal membrane oxygenation" asaio j.2020;66(8):844-846.Doi:10.1097/mat.0000000000001208.

Event Description

Complaint id#(b)(4).

• Brand Name: HLS SET ADVANCED
• 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: 13084476
• MDR Text Key: 282805258
• Report Number: 8010762-2021-00674
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

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 Model Number: HLS SET
• Device Catalogue Number: 701052794
• Device Lot Number: 3000164491 (HLS MODULE)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/24/2021
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1