BERLIN HEART EXCOR VAD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-18 for BERLIN HEART EXCOR VAD manufactured by Berlin Heart, Inc..

Event Text Entries

[4613074] Cannula associated with berlin ventricular assisted device developed a leak on the arterial side.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3956940
• MDR Report Key: 3956940
• Date Received: 2014-07-18
• Date of Report: 2014-07-18
• Date of Event: 2014-07-16
• Date Facility Aware: 2014-07-16
• Report Date: 2014-07-18
• Date Reported to FDA: 2014-07-18
• Date Reported to Mfgr: 2014-07-18
• Date Added to Maude: 2014-07-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BERLIN HEART EXCOR VAD
• Generic Name: EXCOR BLOOD PUMPS WITH PU VALUES
• Product Code: DSQ
• Date Received: 2014-07-18
• Returned To Mfg: 2014-07-18
• Lot Number: 1320140
• ID Number: P15P-001
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 3 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BERLIN HEART, INC.
• Manufacturer Address: 200 VALLEYWOOD RD STE B100 THE WOODLANDS TX 77380 US 77380

Device Sequence Number: 2

• Brand Name: BERLIN HEART EXCOR VAD
• Generic Name: EXCOR APEX CANNULAE
• Product Code: PCK
• Date Received: 2014-07-18
• Returned To Mfg: 2014-07-18
• Lot Number: 0015919
• ID Number: C22A-004
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BERLIN HEART, INC.
• Manufacturer Address: 200 VALLEYWOOD RD STE B100 THE WOODLANDS TX 77380 US 77380

Device Sequence Number: 3

• Brand Name: BERLIN HEART EXCOR VAD
• Generic Name: EXCOR ARTERIAL CANNULAE
• Product Code: PCK
• Date Received: 2014-07-18
• Returned To Mfg: 2014-07-18
• Lot Number: 00023009
• ID Number: C80G-021
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: BERLIN HEART, INC.
• Manufacturer Address: 200 VALLEYWOOD RD STE B100 THE WOODLANDS TX 77380 US 77380

Device Sequence Number: 4

• Brand Name: BERLIN HEART EXCOR VAD
• Generic Name: CONNECTING SET FOR CANNULAE
• Product Code: PCK
• Date Received: 2014-07-18
• Returned To Mfg: 2014-07-18
• Lot Number: 00026212
• ID Number: A06-009
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: BERLIN HEART, INC.
• Manufacturer Address: 200 VALLEYWOOD RD STE B100 THE WOODLANDS TX 77380 US 77380

Device Sequence Number: 5

• Brand Name: BERLIN HEART EXCOR VAD
• Generic Name: PU-VALUES
• Product Code: PCK
• Date Received: 2014-07-18
• Returned To Mfg: 2014-07-18
• Lot Number: 00023827
• ID Number: T006-002
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: BERLIN HEART, INC.
• Manufacturer Address: 200 VALLEYWOOD RD STE B100 THE WOODLANDS TX 77380 US 77380

Device Sequence Number: 6

• Brand Name: BERLIN HEART EXCOR VAD
• Generic Name: DRIVING TUBE
• Product Code: PCK
• Date Received: 2014-07-18
• Returned To Mfg: 2014-07-18
• Lot Number: 0022706
• ID Number: L20H-002
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: BERLIN HEART, INC.
• Manufacturer Address: 200 VALLEYWOOD RD STE B100 THE WOODLANDS TX 77380 US 77380

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2014-07-18