MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problems Partial Blockage (1065); Gradient Increase (1270)

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

Event Date 01/03/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported from the usa that the delta pressure of a hls module increased.The hls set was replaced during treatment.The hls set was discarded by the customer thus no technical product investigation was possible.The patient was infected with covid-19 as confirmed by the customer.As stated by the getinge medical affairs team and in reference to available literature 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 may be the result of a combination of processes driven by covid-19 occurring in synergy with the known effect(s) of the extracorporeal circuit on the coagulation system.Reference: 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.Based on covid-19 as the most probable root cause for the reported failure, clot formation in an extracorporeal circuit can lead to a reduction and/or blockage, and thus, an reduction of the diffusion path lowering the gas transfer performance.With reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, v26) and in consultation with the getinge manager medical affairs team the following events can contribute to clotting in the circuit: air remains in or enters the circuit, inappropriately low, or no blood flow, in the circuit, improper hemostasis, too low anticoagulation, too low act level, effect of heparin is too limited, protamine sulfate enters the hls set, administration of congealable substances (such as platelets) or pro-coagulant medications.(consumption) coagulopathy.The production records of the affected hls module were reviewed on 2022-01-10.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the investigation results no product related malfunction could be confirmed.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.

Event Description

It was reported from the usa that the delta pressure of a hls module increased.The hls set was replaced during treatment.No harm to any person reported.Detailed event description by customer below: it was described to me by customer (b)(6).Went on ecls support on a cardiohelp with hls set that was primed right before use at 1500 on (b)(6) 2022.Patient was a (b)(6) yo covid positive male (b)(6) kg.He was cannulated with two 25 fr venous cannulas in the femoral veins bilaterally for v-v support.Went on with initial flows of 4.4 lpm, rpm of 2946 with int pressure of 133 mmhg and art pressure of 107 mmhg with a delta p of 26 mmhg.At 1530 at same rpm of 2946 flow of 3.94 lpm pressures elevated to int pressure of 194 mmhg, art pressure of 88 mmhg, and a delta p of 106.At 1550 rpm was still 2946 flow dropped to 3.12 lpm with int pressure of 209 mmhg, art pressure 75 mmhg, and delta p of 134 mmhg.At 1555 (b)(6) switched to tandem life circuit.Act was 204 went on 7000 units of heparin at 1450.They used same cannulas with 5000 more units of heparin in the prime when transitioning to tandem life circuit.No act was drawn at this time because of the emergent nature.Tandem life info 5000 rpm 4.6 lpm with no more issues patient is still on this circuit with good flows.Dana took a picture of lot number but not the udi number and discarded the hls set.Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• 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: 13257207
• MDR Text Key: 283814014
• Report Number: 8010762-2022-00006
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1