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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 802100
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 05/08/2018
Event Type  malfunction  
Manufacturer Narrative
As per manufacturer's subsidiary, the ccm has not been used clinically.
 
Event Description
It was reported that during the use of the device for a non-clinical activity, the central control monitor (ccm) touch screen was not working.There was no patient involvement.
 
Manufacturer Narrative
Corrected block: report source: health professional should not have been checked in the initial submission.
 
Manufacturer Narrative
The reported complaint was not verifiable.Per the manufacturer's subsidiary, the user facility found a spare part replacing the defective part and the unit operated as intended.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 Key7557322
MDR Text Key109760832
Report Number1828100-2018-00286
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,distri
Type of Report Initial,Followup,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number802100
Device Catalogue Number802100
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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