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

Model Number HLS SET ADVANCED 7.0

Device Problem Increase in Pressure (1491)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

The customer reported a negative flow on the venous side.The circuit was exchanged.No harm to any person has been reported.Complaint id:(b)(4).

Manufacturer Narrative

The product was requested for investigation as well as further perfusion data.A follow-up emdr will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that a negative flow on the venous side was noted.No information regarding the hls set were provided by the customer.In addition the hls set was not available for technical investigation.A getinge service technician investigated the involved cardiohelp unit on (b)(6) 2022 and no failure or malfunction was noted.The technician performed safety, calibration, and functionality checks to factory specifications.As determined in the hls set risk assessment following probable root causes can lead to the reported event: hls is positioned above patient.Negative pressure on the blood side.Negative pressure in the venous system.Based on the investigation results no product related malfunction could be confirmed.The customer will be made aware of the investigation results.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.H3 other text : 4115.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 13023861
• MDR Text Key: 282381028
• Report Number: 8010762-2021-00658
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET ADVANCED 7.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1