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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 164267
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/20/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Customer wants motor checked out. Per e-mail from the field service representative (fsr) on 27-jun-2016: he spoke with the user facility¿s biomedical engineer (biomed) at the user facility. The biomed is a manufacturer trained biomed for system-1. He is going to follow up with the ccp to see if a repair is needed. Prior to the fsr's call, the biomed was not aware of an issue regarding a centrifugal drive motor.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the pump head in the pack became uncoupled during set-up. The user changed out the head first and still decoupling. They then changed out centrifugal drive motor and it seemed to work. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
 
Manufacturer Narrative
The user facility¿s biomedical engineer (biomed) is manufacturer trained and could not duplicate the reported issue with the centrifugal drive motor. The biomed has requested the field service representative (fsr) to check out the centrifugal drive motor.
 
Manufacturer Narrative
(b)(4). The field service representative (fsr) inspected the centrifugal motor and noted that the window on the motor was cracked and somewhat pushed into the magnets. The fsr installed a different centrifugal motor onto the system 1 base. With the alternate device installed, the unit was tested and operated properly. The unit was released for clinical use. The user facility biomedical engineer (biomed) will send the device to the manufacturer for further evaluation and repair.
 
Manufacturer Narrative
(b)(4). During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint. Although the lab use only (luo) centrifugal pump remained coupled throughout evaluation, the pst observed a loose connection between the luo centrifugal pump and the device under test (dut) centrifugal motor caused by a worn retainer. The product will be sent to service to be brought to manufacturers specifications before being returned to clinical use. 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
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5790244
MDR Text Key50177402
Report Number1828100-2016-00500
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 distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number164267
Device Catalogue Number164267
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2004
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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