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

Device Problem Device Sensing Problem (2917)

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

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Out of a cardiohelp complaint# (b)(4).It has been reported that there was a pressure reading issue (negative pressure).During the investigation of the cardiohelp it was detected that the pressure sensors are found to be the cause of the problem.No harm to any person has been reported.The affected product was not available for technical laboratory investigation of the manufacturer.Thus it was not possible to determine the exact root cause of the reported failure.No more information about which pressures were affected exactly was provided.However, the reported failure "pressure reading issue" can be linked to the following most probable cause according to our risk management file: wrong pressure measurement due to malfunction of the pressure sensor.Based on the investigation results the reported failure "pressure reading issue" could be confirmed.However, it is not possible to determine the exact root cause.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

The event occurred in canada during treatment.Out of a cardiohelp complaint# (b)(4).It has been reported that there was a pressure reading issue (negative pressure).During the investigation of the cardiohelp it was detected that the pressure sensors are found to be the cause of the problem.No more information was provided.No harm to any person has been reported.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16058574
• MDR Text Key: 308469712
• Report Number: 8010762-2022-00529
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1