MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, 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 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

The customer found a defect in the cardiohelp flow sensor.Indeed, they currently have a patient on ecmo vap who has hemolysis problems that have warranted a circuit change.They found at the ablation of the flow sensor that it had slightly pinched the tubing and distorted it, can be favored by the heat released during its operation.The problem is that a fibrin and clot deposit formed just at the "pinch exit." it would seem that this formation is favoured by the modification of the light of the tubing causing turbulence in the flow of blood.Change set had been done.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The hls set was directly involved in the incident which occurred during patient treatment.It was reported that a fibrin and clot debris has been formed where the flow/bubble sensor pinched the tubing.A picture showing the debris was provided by the customer.Maquet gmbh requested the product in question for further investigation on 2020-02-18 but the hls set was not available.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated was performed and no similar complaint was found.As the debris is visible in the picture the failure could be confirmed.According to the hls risk assessment (dms # (b)(4)) following causes can lead to the issue: -particles in circuit due to shear forces; -stenosis in hls set leading to high shear stress and hemolysis.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: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9590171
• MDR Text Key: 200408692
• Report Number: 8010762-2020-00019
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• 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
• Device Lot Number: 70130735
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2020
• Patient Sequence Number: 1