MAUDE Adverse Event Report: SORIN GROUP ITALIA S. R. L. / LIVANOVA USA, INC. CARDIOPULMONARY MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLL

Device Problems Pumping Stopped (1503); No Flow (2991)

Patient Problems Cardiopulmonary Arrest (1765); Emotional Changes (1831); Memory Loss/Impairment (1958); Pain (1994); Cognitive Changes (2551); No Code Available (3191)

Event Date 07/25/2019

Event Type  Injury  

Event Description

Reporter called on behalf of her brother, who experienced an adverse event involving a cardiopulmonary machine.Reporter stated that on (b)(6) 2019 her brother was receiving surgery and the cardiopulmonary machine in use pumped all his blood into the reservoir., but it wouldn't pump back in.Reporter stated that the surgeons checked for blood clots but didn't find anything.Reporter said they cut open her brother's sternum and performed heart massage until a new machine was brought in and the surgery continued fine.Reporter stated that her brother was without oxygen for approx 2-5 mins due to the malfunction of the cardiopulmonary machine.Reporter stated there are noticeable changes with her brother since the event such as pain, extremely short tempered (he was not before the surgery), yelling, changes in personality, doesn't want to work or leave his home, and forgetting things.Reporter feels these changes are related to the event and the lack of oxygen.Reporter stated that her brother has pre-existing learning disability, that seems to have become worse since the event.

• Brand Name: CARDIOPULMONARY MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLL
• Manufacturer (Section D): SORIN GROUP ITALIA S. R. L. / LIVANOVA USA, INC.
• MDR Report Key: 9118985
• MDR Text Key: 160226179
• Report Number: MW5090034
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR