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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 Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This flow sensor was on a delphin centrifugal system. The field service representative (fsr) verified the intermittent operation of the flow sensor. The fsr installed and tested a new flow sensor. The unit operated to manufacturer specifications and was returned to clinical use. The suspect part was returned to the manufacturer for further evaluation.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the flow sensor had failed. The user facility's biomedical engineer (biomed) reported the flow sensor initially worked during setup testing, but then the flow readings stopped. This was resolved by installing a flow sensor from another system. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
 
Manufacturer Narrative
Per follow-up with the field service representative (fsr) on (b)(6) 2016: the circuit was primed and tubing in the flow sensor. Flow displayed and then went to 0. 0. The flow sensor was located between oxygenator and arterial filter on the circuit.
 
Manufacturer Narrative
The reported complaint was confirmed by the field service representative (fsr). During the laboratory evaluation, there was no loss of flow readings occurred during lab testing. The product surveillance technician (pst) operated the flow sensor over a two day period with no dropout in flow readings. The pst agitated the flow sensor¿s head, connector and cable with no loss of flow readings. The pst measured signal strength from the flow sensor and it was 76%. Nothing was observed that would cause failure. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a follow-up emdr 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
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5480298
MDR Text Key39754114
Report Number1828100-2016-00146
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 Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2016
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 Manufacturer02/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2011
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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