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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULE PERFUSION SYSTEM; DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 MODULE PERFUSION SYSTEM; DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM Back to Search Results
Model Number 149673
Device Problem False Alarm (1013)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).As per the field service representative (fsr), the abd was cleaned and the connection to the safety monitor was tightened.The unit operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the air bubble detector (abd) kept alarming.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
 
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Brand Name
SARNS 8000 MODULE PERFUSION SYSTEM
Type of Device
DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS-SARNS 8000 PERFUSION SYSTEM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key6984175
MDR Text Key91354271
Report Number1828100-2017-00491
Device Sequence Number1
Product Code KRL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 10/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number149673
Device Catalogue Number149673
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/02/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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