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

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

Device Problem Pumping Problem (3016)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The sales and service unit informed that the customer did not save the product for investigation.

Event Description

The event occurred in us.It was reported that customer was supporting patient on cardiohelp and noticed air accumulating post oxygenator in the centrifugal pump in the hls mdule.Air was removed and they checked all connections.A time later that same day air was once again seen and they decided to change out the circuit.No indication of actual or potential for harm or death reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that customer was supporting patient on cardiohelp and noticed air accumulating post oxygenator in the centrifugal pump in the hls module.Air was removed and they checked all connections.A time later that same day air was once again seen and they decided to change out the circuit.Customer did not save the circuit for investigation.No indication of actual or potential for harm or death reported has been reported.A review of the trend data for similar complaints was performed and no similar complaints were found.A device history review (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Based on these investigation results and the provided information by the customer, the reported failure "air in the centrifugal pump" cannot be confirmed however the failure mode "air in the centrifugal pump" can be linked to the following most possible root causes according to our risk management file (dms# 1468452) - blood tubing is damaged.- air entry into the hls-set.- flow bubble sensor intervention is disabled.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
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11326889
• MDR Text Key: 233785621
• Report Number: 8010762-2021-00115
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2021
• Patient Sequence Number: 1