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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 CARDIOPLEGIA MONITOR; COMPUTER, BLOOD-PRESSURE-SARNS 8000 CARDIOPLEGIA MONITOR
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 CARDIOPLEGIA MONITOR; COMPUTER, BLOOD-PRESSURE-SARNS 8000 CARDIOPLEGIA MONITOR Back to Search Results
Model Number 16414
Device Problem Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that there was an issue with their cardioplegia monitor.No other details regarding the nature of this event were provided.
 
Event Description
Additional information received that the monitor would not come on and the issue occurred during setup of the device for a cardiopulmonary bypass (cpb) procedure.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
 
Manufacturer Narrative
The reported complaint could not be confirmed.The field service representative (fsr) was not able to duplicate the reported complaint.The cardioplegia (cpg) monitor powered on and functioned properly.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.
 
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Brand Name
SARNS 8000 CARDIOPLEGIA MONITOR
Type of Device
COMPUTER, BLOOD-PRESSURE-SARNS 8000 CARDIOPLEGIA MONITOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key8713855
MDR Text Key148541941
Report Number1828100-2019-00322
Device Sequence Number1
Product Code DSK
Combination Product (y/n)N
PMA/PMN Number
K960916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16414
Device Catalogue Number16414
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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