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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 6382
Device Problem False Alarm (1013)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the flow sensor had a back flow alarm that kept alarming but there were no back flows. The customer continued to use the device. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. As per clinical review: a sarns centrifugal system was being used and was mounted on the sarns 8000 heart lung machine (hlm) base. Periodically during this procedure, backflow alarms occurred even though no backflow conditions were observed. Backflow can be observed by rising of blood levels in the venous reservoir and an associated drop in patient blood pressure and arterial line pressure (cpb circuit). These other indicators of backflow did not exist and thus the backflow alarms were considered false triggers. The case was completed successfully, without delay and without associated blood loss. There was no harm observed.
 
Manufacturer Narrative
The field service representative (fsr) was unable to duplicate the problem. The fsr replaced the flow sensor. The unit operated to manufacturer's specification. 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
Evaluation is in progress, but not yet concluded.
 
Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) could not to reproduce the reported issue. 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 Key6325286
MDR Text Key67535987
Report Number1828100-2017-00064
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6382
Device Catalogue Number6382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2010
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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