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

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2020

Event Type  malfunction  

Event Description

There was a coagulation of the membrane on set be-hls 7050, lot 70130424.The hospital replaced the set and threw away the coagulated set.(b)(4).

Manufacturer Narrative

Device hirstory revord review result: affected product: 70104.6577 be-015703112#hls module advanced adult packaging lot: 70130424 (dms#2762657) production lot: 70129590 (dms#(b)(4)) the documentation for the packaging lot and production lot was reviewed on 2020-06-22.There were no references found, which are indicating a nonconformance of the product in question.A similar case was already investigate under complaint#310782: as stated in the investigation report of ot#310782 clots could be found inside the oxygenator.An increasing delta-p throughout the course of the extracorporeal circulation procedures, including ecmo, is an expected and known side effect.Whereas a rapid increase cannot be regarded as expected, the delta-p can also increase by none-coagulation relating factors, e.G.By ¿pseudofibrine deposits¿ which can be caused or promoted by drugs, such as propofol or by nutrition of the patient.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # (b)(4), v23) 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 thus the 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.

Event Description

Complaint id (b)(4).

• 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: 9773935
• MDR Text Key: 192167146
• Report Number: 8010762-2020-00088
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1