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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

The production records of the affected hls module (dms# (b)(4)) were reviewed on 2021-01-08.According to the final test results, all oxygenators passed the test as per specifications.Production related influences can be excluded.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, a technical investigation of this hls set is not possible as the laboratory of maquet cardiopulmonary (b)(4) is not suitable for who risk group 3.Furthermore, no external laboratory could be found that could carry out the investigation on our behalf.A similar case was already investigated under complaint#(b)(4) on 2020-06-05: as stated in the investigation report of ot#(b)(4) clots could be found inside the oxygenator.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: 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 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.Based on this the reported failure 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

Clotting of ecmo oxygenator during veno-venous ecmo for covid 19.Rise in internal pressure (pint) followed by reduction of flows.Aptt maintained between 50 to 60.Kit used hls 7.0.V-v ecmo initiated on (b)(6) 2020.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): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 11145459
• MDR Text Key: 227110958
• Report Number: 8010762-2021-00007
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: AE
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR