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

Lot Number 70137476

Device Problem Gas/Air Leak (2946)

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

Event Date 05/03/2021

Event Type  malfunction  

Event Description

Ecmo oxygenator failure.During an ecmo oxygenator exchange perfusion observer h2o leaking out of the gas port.Oxygenator was clamped out and exchanged with another oxygenator.Ccm was notified and no adverse patient complication was observed.Fda safety report id# (b)(4).

• Brand Name: ECMO OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 11825070
• MDR Text Key: 250985397
• Report Number: MW5101358
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 05/12/2021

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: No Information
• Device Lot Number: 70137476
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR