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 10/07/2021

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 the us.It was reported that the internal pressure in the hls set was higher than what the customer believed it should be and the delta p pressure got so high and ended up with switching the hls set.No indication of actual or potential for harm or death has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that the internal pressure in the hls set was higher than what the customer believed it should be and the delta p pressure got so high and ended up with switching the hls set.The patient was infected with covid 19.No harm to any person has been reported.The affected hls set with lot#3000163083 was investigated in the getinge laboratory on (b)(6) 2021 with the following results.During the investigation no abnormalities were detected.Further no leakage or functional issue 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] the most probable root cause for the reported failure could be determined as clots which can lead to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.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.Thrombocytopenia.Based on the investigation results the reported failure "internal and delta p pressure increased" could be confirmed, but not product related malfunction.The production history records (dhr) of the affected hls module with lot#3000159541 and serial#(b)(6) were reviewed on (b)(6) 2021.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.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.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: 12622008
• MDR Text Key: 276104395
• Report Number: 8010762-2021-00551
• 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: 12/17/2021

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: 04/08/2022
• Device Model Number: HLS SET
• Device Catalogue Number: 701052794
• Device Lot Number: 3000163083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1