MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS; OXYGENATOR

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

The raceway was being walked by perfusion.When the pump was restarted the raceway ruptured.The cannulas were clamped and volume was given to the pt along with dwindle epi when the bp became low.A cone was cut into the circuit and the pt was put back on at the same flows.

• Type of Device: OXYGENATOR
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 8200 coral sea street ne; mdr product vigilance mvn61; mounds view, mn 55112 MN 55112
• MDR Report Key: 4591947
• MDR Text Key: 5487062
• Report Number: 4591947
• 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?: Yes
• 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