InjuryPCK
BERLIN HEART
Received Apr 19, 2017 · Event occurred Feb 15, 2017
Report MW5069239 · MDR key 6510794
Device
Generic name
Excor Vad Berlin Heart 15ml (ventricular Assist Device)
Manufacturer
Berlin HeartLot number
REF P15P-001
Product problems
- Device Operates Differently Than Expected
Patient
5 MO
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
BERLIN VAD NOTED BY ALARMS AND STAFF NOT TO BE FUNCTIONING PROPERLY. VAD ASSESSED TO NOT BE EJECTING AND PATIENT WITH ACUTE DECOMPENSATION. MD AND SURGICAL TEAM CALLED TO BEDSIDE AND WITH IMMEDIATE RESPONSE AND SURGICAL INTERVENTION TO CHANGE VAD. POTENTIAL DELAMINATION OF MEMBRANE NOTED BY SURGEON.