VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM 48VMP106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM 48VMP106 manufactured by Edwards Lifesciences Dr.

MAUDE Entry Details

• Report Number: 2015691-2019-03307
• MDR Report Key: 8962836
• Date Received: 2019-09-04
• Date of Report: 2019-06-13
• Date of Event: 2019-06-13
• Date Mfgr Received: 2019-09-10
• Device Manufacturer Date: 2019-01-09
• Date Added to Maude: 2019-09-04
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS SAMANTHA EVELEIGH
• Manufacturer Street: 1 EDWARDS WAY
• Manufacturer City: IRVINE CA 92614
• Manufacturer Country: US
• Manufacturer Postal: 92614
• Manufacturer Phone: 9492503939
• Manufacturer G1: EDWARDS LIFESCIENCES DR
• Manufacturer Street: PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5
• Manufacturer City: HAINA, SAN CRISTOBAL
• Manufacturer Country: DR
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
• Generic Name: KIT, SAMPLING, ARTERIAL BLOOD
• Product Code: CBT
• Date Received: 2019-09-04
• Returned To Mfg: 2019-07-23
• Model Number: 48VMP106
• Lot Number: 61804823
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EDWARDS LIFESCIENCES DR
• Manufacturer Address: PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-04