MEDTRONIC ECMO OXYGENATOR MEMBRANE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-01 for MEDTRONIC ECMO OXYGENATOR MEMBRANE * manufactured by Medtronic Perfusion Systems.

Event Text Entries

[400850] Two ecmo membranes (not yet connected to a patient) were being primed with fluid. A nurse noticed that membrane #1 was leaking, and noticed a couple of days later that membrane # 2 was leaking. The vendor was notified, and a representative arrived on site to examine the membranes and to return them to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 582446
• MDR Report Key: 582446
• Date Received: 2005-03-01
• Date of Report: 2005-03-01
• Date of Event: 2005-02-27
• Report Date: 2005-03-01
• Date Reported to FDA: 2005-03-01
• Date Added to Maude: 2005-03-19
• 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: 0
• 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: MEDTRONIC ECMO OXYGENATOR MEMBRANE
• Generic Name: ECMO MEMBRANE
• Product Code: BYS
• Date Received: 2005-03-01
• Returned To Mfg: 2005-02-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: R
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 572274
• Manufacturer: MEDTRONIC PERFUSION SYSTEMS
• Manufacturer Address: 7611 NORTHLAND DRIVE MINNEAPOLIS MN 55428 US

Device Sequence Number: 2

• Brand Name: MEDTRONIC ECMO OXYGENATOR MEMBRANE
• Generic Name: ECMO MEMBRANE
• Product Code: BYS
• Date Received: 2005-03-01
• Returned To Mfg: 2005-02-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 572275
• Manufacturer: MEDTRONIC PERFUSION SYSTEMS
• Manufacturer Address: 7611 NORTHLAND DRIVE MINNEAPOLIS MN 55428 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-03-01