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

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Improper Chemical Reaction (2952)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.(b)(4).

Event Description

Oxygenator changed due to inadequate oxygenation of blood , which resulted in desaturation of patient while he is on ecmo support.The kit was replaced with new hls kit and ecmo continued.Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "inadequate oxygenation" occurred during treatment.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 gmbh 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 "inadequate oxygenation" in the oxygenator could be determined as clots this can lead to a blockage and thus an extension of the diffusion path lowering the oxygenating performance.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4), v25) following 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 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.Device history record (dhr) was performed of the affected product and there were no references found, which are indicating a nonconformance of the product in question.The reported failure "inadequate oxygenation" occurred during treatment and 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.

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: 10968339
• MDR Text Key: 220221277
• Report Number: 8010762-2020-00424
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Device Lot Number: 70138816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1