MAUDE Adverse Event Report: LIVANOVA USA INSPIRE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Device Problems Defective Component (2292); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 12/01/2020

Event Type  No Answer Provided  

Event Description

Oxygenator failed: while the patient was on bypass, the heart lung machine oxygenator failed, the patient had to come off bypass for three minutes and the oxygenator was replaced with no apparent injury to the patient.

• Brand Name: INSPIRE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 11027141
• MDR Text Key: 222041298
• Report Number: 11027141
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA