FDA Adverse Event Injury Summary report: N

THORATEC PVAD

MDR report key: 3150815 · Received June 6, 2013

Report

Report Number
3150815
Event Type
Injury
Date Received
June 6, 2013
Date of Event
October 18, 2008
Report Date
June 6, 2013
Manufacturer
THORATEC CORPORATION
Product Code
DSQ
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
AL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

FIBRIN NOTED IN RVAD PUMP DURING MEDIASTINAL EXPLORATION FOR LOW RVAD FLOWS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
250931 THORATEC PVAD BIVAD DSQ THORATEC CORPORATION

Patients

Seq Age Sex Outcome Treatment
1