MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 5050#HLS SET ADVANCED 5.0

Device Problems No Flow (2991); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  malfunction  

Event Description

Massive increasing of transmembrane pressure, no flow on system, customer had to finished therapy.(b)(4).

Event Description

Complaint id:(b)(4).

Manufacturer Narrative

The device history record of the product was reviewed on(b)(6)2020 and there were no references found, which are indicating a nonconformance of the product in question.A similar case was already investigated under complaint#310782 on 2020-06-05: as stated in the investigation report of ot#310782 clots could be found inside the oxygenator.These clots are leading to a blockage of the oxygenator and the rising delta pressure.Due to the impaired blood flow and extension of the diffusion path the oxygenation performance is decreased.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v25) 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 -low antithrombin (at iii) -(consumption) coagulopathy -thrombozytopenia for further evaluation a medical review was performed by manager medical affairs on 2020-09-02.Results of medical review: an increasing delta p is directly reflective of a reduction in available membrane surface area.Oftentimes, this reduction is result of an accumulation of formed elements on the membrane (clot, platelets, fibrinogen, etc.) during support.The following scenarios may contribute to the increase in delta p: -low flow within the hls set advanced 5.0 -hypercoagulopathic patient -insufficient anticoagulation -removal of heparin via cvvh/crrt/hemofiltration depending on sieving coefficient of the unfractionated heparin used relative to the hemofilter selected.-increased surface area for activation of clotting factors from the addition of a cvvh/crrt/hemofiltration circuit to a extracorporeal support circuit.-while rare, tuberculosis can affect coagulation in very small subset of patients.Thus the 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.H3 other text : 4115.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9820861
• MDR Text Key: 190538494
• Report Number: 8010762-2020-00097
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: BE-HLS 5050#HLS SET ADVANCED 5.0
• Device Catalogue Number: 70104.8127
• Device Lot Number: 70133177
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 18 MO