ECMO MEMBRANE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for ECMO MEMBRANE * manufactured by Medtronic Perfusion Systems.

Event Text Entries

[393057] Nursing staff noticed that 4 ecmo membranes (not yet connected to patients) that were primed with fluid were leaking. Membrane #1 leaked during assembly for priming with fluid. Membrane #2 leaked a few hours after it had been primed with fluid. Membrane # 3 and membrane # 4 were noticed to be leaking at some point after they had been primed with fluid, but the exact time of the start of the leak is unknown. Again, these membranes were not attached to patients. The site continues to use these membranes from medtronic and continue to check for leaking. However, the 4 membranes in question have been returned to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 572183
• MDR Report Key: 572183
• Date Received: 2005-02-02
• Date of Report: 2005-02-01
• Date of Event: 2005-01-29
• Report Date: 2005-02-01
• Date Reported to FDA: 2005-02-02
• Date Added to Maude: 2005-02-14
• 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: ECMO MEMBRANE
• Generic Name: ECMO MEMBRANE
• Product Code: BYS
• Date Received: 2005-02-02
• Returned To Mfg: 2005-02-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 562055
• Manufacturer: MEDTRONIC PERFUSION SYSTEMS
• Manufacturer Address: 7611 NORTHLAND DR MINNEAPOLIS MN 55428 US

Device Sequence Number: 2

• Brand Name: MEDTRONIC ECMO OXYGENATOR MEMBRANE
• Generic Name: ECMO MEMBRANE
• Product Code: BYS
• Date Received: 2005-02-02
• Returned To Mfg: 2005-02-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 562056
• Manufacturer: MEDTRONIC, INC.
• Manufacturer Address: 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US

Device Sequence Number: 3

• Brand Name: MEDTRONIC ECMO OXYGENATOR MEMBRANE
• Generic Name: ECMO MEMBRANE
• Product Code: BYS
• Date Received: 2005-02-02
• Returned To Mfg: 2005-02-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 562057
• Manufacturer: MEDTRONIC, INC.
• Manufacturer Address: 7611 NORTHLAND DR MINNEAPOLIS MN 55428 US

Device Sequence Number: 4

• Brand Name: MEDTRONIC ECMO OXYGENATOR MEMBRANE
• Generic Name: ECMO MEMBRANE
• Product Code: BYS
• Date Received: 2005-02-02
• Returned To Mfg: 2005-02-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DY
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 562058
• Manufacturer: MEDTRONIC, INC.
• Manufacturer Address: 7611 NORTHLAND DR MINNEAPOLIS MN 55428 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-02-02