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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 Back to Search Results
Model Number 16402
Device Problem Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2018
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, there was an overspeed error message displayed.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
 
Manufacturer Narrative
The reported complaint was not confirmed.The field service representative (fsr) performed a release test and observed that the heart lung machine (hlm) and roller pump are operating within 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 UNIVERSAL ROLLER PUMP
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key8222800
MDR Text Key132946573
Report Number1828100-2019-00012
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
PMA/PMN Number
K953901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 03/15/2019
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 Number16402
Device Catalogue Number16402
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/13/2018
Initial Date FDA Received01/07/2019
Supplement Dates Manufacturer Received01/07/2019
03/04/2019
Supplement Dates FDA Received01/31/2019
03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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