MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS; OXYGENATOR

Device Problem Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 02/11/2015

Event Type  No Answer Provided  

Event Description

Blood was noted in the raceway compartment.Perfusionist called to bedside.Pt off ecmo for replacement of raceway tubing.Tubing replaced at hour 175 of ecmo.Pt received 1ml dwindle epi.Pt placed back on ecmo.Hole found in tubing by perfusionist.

• Type of Device: OXYGENATOR
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 8200 coral sea street ne; mdr product vigilance mvn61; mounds view MN 55112
• MDR Report Key: 4591939
• MDR Text Key: 5486586
• Report Number: 4591939
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1