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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO ADVANCED PERFUSION SYSTEM ONE; CARDIOPULMONARY BYPASS MACHINE
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TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO ADVANCED PERFUSION SYSTEM ONE; CARDIOPULMONARY BYPASS MACHINE Back to Search Results
Model Number 801763
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Neurological Deficit/Dysfunction (1982)
Event Date 03/25/2014
Event Type  Injury  
Event Description
Patient had been placed back on bypass during cabg due to sudden change in cardiac status.Shortly after bypass initiated, air was noted in the arterial circulation of the pump circuit.Source of air unknown.Bypass was stopped and protocols followed in an effort to evacuate air.Bypass was then re-initiated and procedure continued with patient successfully taken off bypass.Post-op, patient unable to respond to commands and has no purposeful movement at this time.
 
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Brand Name
TERUMO ADVANCED PERFUSION SYSTEM ONE
Type of Device
CARDIOPULMONARY BYPASS MACHINE
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEM CORP.
ann arbor MI 48103
MDR Report Key3846926
MDR Text Key4616797
Report Number3846926
Device Sequence Number1
Product Code DTQ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/02/2014
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? No
Device Operator Health Professional
Device Model Number801763
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/02/2014
Distributor Facility Aware Date03/26/2014
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer04/02/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/05/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MEDTRONIC DLP 753202 STRAIGHT TIP 20F ARTERIAL; TERUMO CARDIOVASCULAR PROCEDURE KIT: (B)(4); VENOUS CANNULA; CANNULA; EDWARDS LIFESCIENCES TR 3240L 2-STAGE VENOUS 32/40; TERUMO OXYGENATOR: #535913K
Patient Outcome(s) Disability;
Patient Age73 YR
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