MAUDE Adverse Event Report: THORATEC THORATEC CENTRIMAG 34FR DRAINAGE CANNULA KIT

Catalog Number PL-0220

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 02/08/2014

Event Type  Injury  

Event Description

Cannula connector fractured circumferentially on one cannula and partially on second in use on lvad centrimag.Dates of use: (b)(6) 2014.Diagnosis or reason for use: cardiogenic shock.

• Brand Name: THORATEC CENTRIMAG 34FR DRAINAGE CANNULA KIT
• Type of Device: CANNULA
• Manufacturer (Section D): THORATEC
• MDR Report Key: 3628118
• MDR Text Key: 19922624
• Report Number: MW5034413
• Device Sequence Number: 1
• Product Code: DWA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PL-0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 100