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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Increase in Pressure (1491)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The affected hls set is requested for further investigation in the getinge laboratory but not received yet.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6).It was reported that the hls module made a high frequency sound and delta p increased.The hls set was replaced.No indication of actual or potential for harm or death has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in (b)(6).It was reported that the hls module made a high frequency sound and delta pressure increased.The hls set was replaced with another one with no consequences for the patient.No harm to the patient has been reported.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] 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.With reference to the risk assessment hls set advanced 5.0 / hls set advanced 7.0, dms#(b)(4), v26 and in consultation with the getinge manager medical affairs the following events can contribute to clotting in the circuit: air remains in or enters the circuit; hemostasis; air or blood remains in luer lock access port; too low anticoagulation; too low act level, effect of heparin is too limited; protamine sulfate enters the hls set; administration of substitution of congealable substance such as plateltes; (consumption) coagulopathy; thrombozytopenia.The device history records (dhr) of the affected hls module were reviewed on 2021-06-21.Following tests are performed 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, all hls modules passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "delta p increased" could be confirmed.The most probable root cause for the increased pressure drop are clots in the oxygenator leading to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.This is further strengthened by the reported ¿high frequency sound¿, our medical experts have confirmed that clots can cause a change of the pump sound is.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: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11722955
• MDR Text Key: 247254549
• Report Number: 8010762-2021-00270
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2020
• Patient Sequence Number: 1