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 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is on going.A follow up medwatch will be submitted when additional information becomes available.

Event Description

It was reported that during treatment the delta p was increased, resulting in reduction of flows in used ecmo circuit.The patient was infected with covid-19.The hls set was replaced.Complaint : (b)(4).

Event Description

Complaint# (b)(4).

Manufacturer Narrative

It was reported that during treatment the delta p was increased, resulting in reduction of flows in used ecmo circuit.The set was replaced.The patient was infected with covid-19.Covid-19 diseases can be associated with intravascular coagulation activation, microcirculation disorders and increased risk of thromboembolism despite good systemic anticoagulation.Due to the high risk of spreading the sars-cov-2 virus outside the healthcare environment the product was discarded by the customer, therefore a technical investigation of this hls set is not possible at the laboratory of maquet cardiopulmonary gmbh.The most probable root cause for the reported failure are clots in the oxygenator leading to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.According to our risk management file (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4) , v26) following most possible root causes could lead to coagulation: de-airing luer lock connection too loose; air remains in or enters the circuit; hemostasis; air or blood remains in luer lock access port; 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 (dms#(b)(4) , 3105271 ) were reviewed on 2021-05-11.Following tests are performed according to the bop as a 100 % inspection: leak test after welding; pressure test heat exchanger; leak test water side; leak and flow test gas side; pressure test blood side; coating test.According to the final test results, all oxygenators passed the test as per specifications.Production related influences can be excluded.Based on these investigation results and the given information the reported failure could be confirmed.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: 11435002
• MDR Text Key: 239814948
• Report Number: 8010762-2021-00150
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2021
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 70106.9073
• Device Lot Number: 70145335
• Date Manufacturer Received: 05/07/2021
• Patient Sequence Number: 1
• Patient Weight: 80