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

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

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2020

Event Type  malfunction  

Event Description

Veno-veno ecls support for covid-19 patient supported with cardiohelp hls 7.0 circuit began experiencing delta pressure changes that suddenly elevated to 350mmhg with flow changes of 3.5lpm to 1lpm.No visible clot seen in circuit.Perfusionist managing circuit reports that act was "adequate ".Circuit was urgently replaced due to inadequate flow changes to support patient.Circuit was examined for visible clots that were not noted.Circuit was not saved for examination and was discarded.Complaint id: (b)(4).

Event Description

Complaint id (b)(4).

Manufacturer Narrative

Device history record(dhr)review result: the dhr for the hls module advanced adult (material: 70105.4379, lot: 70134563, dms#2885026) for which a customer complaint was received, was reviewed on 2020-06-22.The dhr does not show any abnormality or issue that is related or can have led to the customer complaint.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.A similar case was already investigated under complaint(b)(4) on (b)(6)2020 : as stated in the investigation report of ot#310782 clots could be found inside the oxygenator.The most probable root cause are clots in the oxygenator leading to a blockage.According to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, 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 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.

• Brand Name: HLS SET ADVANCED 7.0 WITH BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10057530
• MDR Text Key: 191323250
• Report Number: 8010762-2020-00161
• 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: 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: 05/14/2020
• 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
• Device Lot Number: 70134563 (MODULE)
• 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