DLP LEFT HEART VENT CATHETER 12016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-06-12 for DLP LEFT HEART VENT CATHETER 12016 manufactured by Perfusion Systems.

MAUDE Entry Details

• Report Number: 2184009-2019-00038
• MDR Report Key: 8691949
• Report Source: FOREIGN,HEALTH PROFESSIONAL,L
• Date Received: 2019-06-12
• Date of Report: 2019-07-22
• Date of Event: 2019-01-25
• Date Mfgr Received: 2019-07-03
• Date Added to Maude: 2019-06-12
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PHYSICIAN ASSISTANT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: PAULA BIXBY
• Manufacturer Street: 8200 CORAL SEA STREET NE
• Manufacturer City: MOUNDS VIEW MN 55112
• Manufacturer Country: US
• Manufacturer Postal: 55112
• Manufacturer Phone: 7635055378
• Manufacturer G1: PERFUSION SYSTEMS
• Manufacturer Street: 7611 NORTHLAND DR
• Manufacturer City: BROOKLYN PARK MN 55428
• Manufacturer Country: US
• Manufacturer Postal Code: 55428
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DLP LEFT HEART VENT CATHETER
• Generic Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Product Code: DTS
• Date Received: 2019-06-12
• Model Number: 12016
• Catalog Number: 12016
• Lot Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PERFUSION SYSTEMS
• Manufacturer Address: 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-06-12