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

Model Number BEQ-HLS 5050-CA#HLS SET ADVANCED 5.0

Device Problem Failure to Deliver (2338)

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

Event Date 04/22/2021

Event Type  malfunction  

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.

Event Description

The event occurred in (b)(6).It was reported that while supporting a patient of veno-veno ecls- cardiohelp hls set advanced 5.0 the patient venous saturation remained low.A circuit change out was required.Hls set was discarded due to covid 19.No indication of actual or potential for harm or death has been reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in canada.It was reported that while supporting a patient of veno-veno ecls- cardiohelp hls set advanced 5.0 the patient venous saturation remained low.A circuit change out was required.The circuit was successfully changed out.Hls set was discarded due to covid 19.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 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 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 most probable root cause for the low saturation could be clots in the oxygenator which could lead to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.The production history records (dhr) of the affected hls module were reviewed on 2021-07-20.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, all hls modules passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "low saturation" could be confirmed, but not product related malfunction.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: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11744726
• MDR Text Key: 249759837
• Report Number: 8010762-2021-00276
• 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: 07/21/2021

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 Expiration Date: 10/17/2021
• Device Model Number: BEQ-HLS 5050-CA#HLS SET ADVANCED 5.0
• Device Catalogue Number: 701064848
• Device Lot Number: 70135234
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/22/2021
• Patient Sequence Number: 1