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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULAR PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULAR PERFUSION SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM Back to Search Results
Model Number 16402
Device Problem Break (1069)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The fsr replaced the broken molded tongue.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 roller pump had a broken molded tongue.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
SARNS 8000 MODULAR PERFUSION SYSTEM
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key10992729
MDR Text Key220961351
Report Number1828100-2020-00475
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K915183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number16402
Device Catalogue Number16402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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