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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 801046
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2017
Event Type  malfunction  
Event Description
It was reported that during the use of the device for a non-clinical activity, the centrifugal control unit (ccu) did not work.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.Multiple diligence attempts were unsuccessful for further information on repairs done and part return for evaluation.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 Key7952306
MDR Text Key123259373
Report Number1828100-2018-00542
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,foreig
Type of Report Initial,Followup
Report Date 11/30/2018
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 Other
Device Model Number801046
Device Catalogue Number801046
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/20/2018
Initial Date FDA Received10/10/2018
Supplement Dates Manufacturer Received11/29/2018
Supplement Dates FDA Received11/30/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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