MalfunctionPCK

BERLIN HEART EXCOR VAD

Received Apr 1, 2016 · Event occurred Mar 18, 2016

Report MW5061459 · MDR key 5546856

Device

Generic name

Berlin Heart Excor Vad

Manufacturer

Berlin Heart

Model number

P10P 10M

Lot number

1320554

Product problems

Device Contamination with Chemical or Other Material

Patient

1 MO

No Information
No Information

Narrative

Description of Event or Problem

PERFUSION WAS PRIMING BERLIN HEART EXCOR VAD (P10P 10M #(B)(4)) AND DISCOVERED PLASTIC IN THE VALVE OF THE HEART WHICH COULD NOT BE REMOVED THROUGH PRIMING. THEREFORE A SECOND BACKUP BERLIN HEART WAS PRIMED AND USED.