MAUDE Adverse Event Report: SORIN GROUP USA, INC. STOCKERT S5 HEART-LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 48-50-00

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 10/05/2018

Event Type  malfunction  

Event Description

The cardiopulmonary bypass machine (cpbm) started to alarm, and eventually malfunctioned.Cpbm with blanketrol and heater cooler machine.New machine obtained.Also, the model# for this device is 48-50-00.

• Brand Name: STOCKERT S5 HEART-LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC.; livanova usa, inc.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 8068607
• MDR Text Key: 127125943
• Report Number: 8068607
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 48-50-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA