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

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Gradient Increase (1270)

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

Event Date 03/07/2021

Event Type  malfunction  

Manufacturer Narrative

The product and patient data were requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The following was reported by the customer: "customer had a patient on cardiohelp vv ecls.Over the course of 24 hours from 3/6/21 to 3/7/21, the delta p went from mid 20¿s to 140 and the pre pressure increasing as well over that time period.Please see attachment.The columns are recorded in 8 hour intervals and during that period please note the venous values which are ¿ values as they should be and then below are pre, post and delta p.You can also see on 3/7/21 at 1800 the circuit was changed and the pressures normalized.But before the circuit change, all values and increasing work was indicative of a clot on the pre membrane side.Flow was stopped, isolated the venous line and clamped off the patient and cut the venous line circuit and power flushed from the quick connect port on the oxygenator, the entire oxygenator and venous line.The entire circuit except for return line (red taped) line was rinsed with saline.No clots were in power flushed circuit nor in the venous line.We reconnect the venous line to the circuit and resumed therapy.Even with this power flush we were not able to identify any obstruction (clot) but to no avail the exact same pre pressure and delta p was on console.No harm was done to patient, just feel there could be an issue with the disposable.".

Manufacturer Narrative

It was reported that the delta pressure increased during treatment.The hls module was investigated in the laboratory on 2021-04-27 with following results: during visual inspection no abnormalities were detected.Further no leakage or functional issue of the pump could be confirmed.The hls module worked according to its specifications.The production records of the affected hls module were reviewed on 2021-05-28.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences can be excluded.The customer reported that the patient was covid-19 positive.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.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 # 1468452, 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.Based on the investigation results the reported failure "delta pressure increase" could be confirmed but no product related malfunction.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

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
• MDR Report Key: 11526902
• MDR Text Key: 246484233
• Report Number: 8010762-2021-00199
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Date Manufacturer Received: 05/28/2021
• Patient Sequence Number: 1