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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 195215
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 08/20/2020
Event Type  malfunction  
Manufacturer Narrative
The field service representative (fsr) replaced the level sensor.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.
 
Event Description
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the level sensor had a deteriorating membrane and was intermittently working.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.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 Key10531756
MDR Text Key207120275
Report Number1828100-2020-00350
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K172220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number195215
Device Catalogue Number195215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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