MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN 3T; HEATER AND COOLER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Dyspnea (1816); Fainting (1847); Fatigue (1849); Vomiting (2144); No Code Available (3191)

Event Date 03/04/2018

Event Type  malfunction  

Event Description

At the time of the surgery and intraoperatively, there were no concerns or issues with the sorin 3t.Fainted three times in (b)(6) on different days.At this time pt also had significant fatigue and shortness of breath with exertion that pt though was secondary to asthma.In (b)(6) pt began to have diarrhea, vomiting, and stomach pain and presented to the ed.Pt was discharged home with zofran.One week later pt's vomiting persisted and re-presented to the ed where an echo was performed and was found to have severe dilated cardiomyopathy and acalculous cystitis.Serial echo demonstrating poor cardiac output with ef less than 12% and pt was ultimately listed as needing heart transplant.An lvad was required due to his rapid decompensation along with intubation.

Event Description

At the time of the surgery and intraoperatively, there were no concerns or issues with the sorin 3t.Fainted three times in october [] on different days.At this time pt also had significant fatigue and shortness of breath with exertion that pt though was secondary to asthma.In (b)(6) pt began to have diarrhea, vomiting, and stomach pain and presented to the ed.Pt was discharged home with zofran.One week later pt's vomiting persisted and re-presented to the ed where an echo was performed and was found to have severe dilated cardiomyopathy and acalculous cystitis.Serial echo demonstrating poor cardiac output with ef < 12% and pt was ultimately listed as needing heart transplant.An lvad was required due to his rapid decompensation along with intubation.

• Brand Name: SORIN 3T
• Type of Device: HEATER AND COOLER
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 9488399
• MDR Text Key: 171826723
• Report Number: 9488399
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6570 DA
• Patient Weight: 55