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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM Back to Search Results
Model Number 6379
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2016
Event Type  malfunction  
Manufacturer Narrative
The reported complaint was not confirmed. The service repair technician (srt) set varied speed and flow settings with multiple flow sensors. No fluctuations at any speed and flow settings were observed. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Manufacturer Narrative
(b)(4). The field service representative (fsr) tested the device ans was unable to verify the reported issue. The fsr did note the flow probe signal strength was only reading 36%. The device was returned for further evaluation.
 
Event Description
It was reported that during priming of the device for a cardiopulmonary bypass procedure, the centrifugal controller had a slow flow reading, fluctuating from 2l/min - 5l/min. 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
During laboratory analysis, the product surveillance technician (pst) connected a centrifugal motor and flow sensor to the centrifugal control module. Pst operated the module at flow rates from 0-9 l/min with no fluctuations in flow readings. Operated the module for three days with no failure occurring. 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 NameSARNS CENTRIFUGAL SYSTEM
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
eileen dorsey
6200 jackson road
ann arbor, MI 48103
7347416074
MDR Report Key6237780
MDR Text Key198696604
Report Number1828100-2017-00017
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6379
Device Catalogue Number6379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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