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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1 Back to Search Results
Model Number 6382
Device Problem False Alarm (1013)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2020
Event Type  malfunction  
Event Description
It was reported that the flow sensor had a back flow alarm.No other details regarding the nature of this event were provided.
 
Event Description
Additional information was received stated that the issue occurred during set-up of the device for a cardiopulmonary bypass (cpb) procedure.The surgical procedure was completed successfully.
 
Manufacturer Narrative
The reported complaint was not verifiable.Multiple diligence attempts for part return were unsuccessful so an evaluation could not be completed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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Brand Name
ADVANCED PERFUSION SYSTEM 1
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS- ADVANCED PERFUSION SYSTEM 1
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key9878167
MDR Text Key192155781
Report Number1828100-2020-00137
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K022947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 05/06/2020
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 Health Professional
Device Model Number6382
Device Catalogue Number6382
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/03/2020
Initial Date FDA Received03/25/2020
Supplement Dates Manufacturer Received03/23/2020
04/16/2020
Supplement Dates FDA Received04/13/2020
05/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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