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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 Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
Per fsr, the minimum and maximum labels are no longer available.The unit operated to the manufacturer's specifications.
 
Event Description
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the unit had a missing label that identifies the minimum and maximum fill levels.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.As per the field service representative (fsr), there were no parts available for replacement due to part obsolescence.The end-user was still using the unit as a back-up.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 Key7578558
MDR Text Key110457645
Report Number1828100-2018-00297
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
Type of Report Initial,Followup
Report Date 10/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number4415
Device Catalogue Number4415
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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