inforMED
DeathDSQ

BERLIN HEART EXCOR VAD

Received Jul 18, 2014 · Event occurred Jul 16, 2014

Report 3956940 · MDR key 3956940

Device

Generic name

Excor Blood Pumps With Pu Values

Manufacturer

Berlin Heart, Inc.

Lot number

1320140

Product problems

  • Break
  • Leak/Splash
  • Device Operates Differently Than Expected

Patient

13 MO

  • Cardiac Arrest
  • Embolism
  • Hemorrhage/Blood Loss/Bleeding

Narrative

Description of Event or Problem

CANNULA ASSOCIATED WITH BERLIN VENTRICULAR ASSISTED DEVICE DEVELOPED A LEAK ON THE ARTERIAL SIDE.