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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING Back to Search Results
Model Number 4415
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Patient Involvement (2645)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
The reported issue was discovered during routine testing of the unit.As per field service representative (fsr), the unit was found out to be end of service life (eosl) and repairs were not done.
 
Event Description
It was reported that during the use of the device for a non-clinical activity, the heater cooler had a low flow.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was not verifiable.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
SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
Type of Device
CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key8371596
MDR Text Key139187141
Report Number1828100-2019-00094
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
PMA/PMN Number
K883603
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/27/2019
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 Number4415
Device Catalogue Number4415
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/01/2019
Initial Date FDA Received02/26/2019
Supplement Dates Manufacturer Received03/08/2019
Supplement Dates FDA Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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