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

Model Number QUADROX-ID PEDIATRIC

Device Problem Increase in Pressure (1491)

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

Event Date 04/23/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that the delta pressure increased during patient treatment.No visible clots were noted.The quadrox-id pediatric was exchanged with an hls set during patient treatment.The affected products were not available for technical investigation of the manufacturer.The reported event "delta pressure increased" was not investigated within a previous complaint.Thus the exact root cause of the reported event could not be determined.Therefore it was not possible to confirm the reported failure "delta pressure increased".However in accordance to the risk assessment (quadrox-id, pediatric) the reported failure could be linked to the following most probable root causes: -blockage of oxygenator, -increasing pressure drop, -impaired blood flow, -deteriorating gas transfer, -insufficient anticoagulation, -hemostasis.Based on the investigation results the reported failure could not be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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 the us.It was reported that the delta pressure increased during patient treatment.No visible clots were noted.The quadrox-id pediatric was exchanged with an hls set during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

• Brand Name: OXYGENATOR
• 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: 14268419
• MDR Text Key: 293001319
• Report Number: 8010762-2022-00140
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUADROX-ID PEDIATRIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1