MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Device Problems Self-Activation or Keying (1557); Low Readings (2460); Calibration Problem (2890); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2013

Event Type  malfunction  

Event Description

Heart/lung machine started automatic calibration of o2 analyzer during rewarming.Aortic cross clamp on.Heard hissing sound (as if there was a gas pressure release); inspected all aspects of circuit and found source was internal gas system of the terumo advanced system.Noticed "cal" readout on touch-screen under fio2 display.Also noticed gas flow and fio2 had dropped to the lowest start-up setting of 21% oxygen and just under 0.5 lpm of gas flow.About 20 seconds between hissing sound and discovering source.The pao2 display on the terumo cdi had the lowest reading of 120mmhg and pco2 was in the low 60s.Overrode auto-calibration by increasing gas flow and fio2 on the touch screen and "cal" display disappeared.No patient harm.

• Brand Name: TERUMO ADVANCED SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson rd.; ann arbor MI 48103
• MDR Report Key: 3590727
• MDR Text Key: 4164372
• Report Number: 3590727
• 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
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2014
• Patient Sequence Number: 1
• Patient Age: 51 YR