MAUDE Adverse Event Report: MEDTRONIC INC. PERFUSION OPEN HEART PACK - OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number TL5X08R11

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  Injury  

Event Description

On (b)(6) 2018 the patient underwent an aortic and mitral valve replacement.Immediately upon undergoing cardiopulmonary bypass, there was a difficulty maintaining the patient's oxygenation.A thorough inspection machine revealed that the piece of the oxygenator was broken.The patient was taken off the bypass machine and the oxygenator was replaced.The procedure continued and tolerated by the patient fairly well.Post procedure the patient was transferred to cvicu.

• Brand Name: PERFUSION OPEN HEART PACK - OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 7540337
• MDR Text Key: 109281470
• Report Number: MW5077416
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2019
• Device Model Number: TL5X08R11
• Device Lot Number: 214315945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Weight: 76