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

Lot Number 300205641

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

A slow blood drip was noted on the inlet connection of the quadrox oxygenator.Changed out oxygenator.Fda safety report id# (b)(4).

• Brand Name: OXYGENATOR, QUADROX
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 14488251
• MDR Text Key: 292613445
• Report Number: MW5109846
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 300205641
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female