MAUDE Adverse Event Report: TERUMO MEDIAL CORP TERUMO HEART LUNG MACHINE

Device Problem Device Inoperable (1663)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/14/2014

Event Type  Injury  

Event Description

During cardiac surgery, while the pt was on cardiac bypass, the machine unexpected shut down.An attempt to re-start the machine was unsuccessful and hand cranking was required while another bypass machine was obtained.

• Brand Name: TERUMO HEART LUNG MACHINE
• Type of Device: TERUMO HEART LUNG MACHINE
• Manufacturer (Section D): TERUMO MEDIAL CORP; somerset NJ 08870
• MDR Report Key: 3902342
• MDR Text Key: 4676186
• Report Number: 3902342
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2014
• Distributor Facility Aware Date: 04/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 53 YR