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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 Type  Injury  
Manufacturer Narrative
(b)(4). The field service representative (fsr) only heard the motor throttling down. The fsr verified the reported issue when running the centrifugal control module at 2400 rpm it dropped to about 700 rpm for about a second and came back up. After duplicating the problem, he began to inspect the internal components. They were covered in dust, so the fsr cleaned the components, retested and duplicated problem again. The fsr then disconnected the motor cable from module and inspected the pins. The pins were caked with black particles (dendrite in appearance). The fsr cleaned the pins and tightened connection to the control module. He was unable to duplicate the reported issue. The unit operated to manufacturer specifications and was returned to clinical use. There will be no part returned for evaluation.
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass procedure, the speed was set at 2400 revolutions per minute (rpm) for the centrifugal control module, then it dropped to between 800 and 1200 rpms with no external changes made. 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 confirmed. Per the field service representative (fsr), black particles were little on both control module and motor end but they were mostly on motor end. Cable strain relief was not damaged and the black particle was dendrites, not fluid ingress. 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
Event date: diligence determined the date of the event was possibly (b)(6), 2015. The field service representative informed the customer they should check and clean the contaminated cables before using the device per operator's manual, "after each use, clean the surface of the entire system to remove spilled fluids, blood, etc. Place the protective cover over the drive motor receptacle during storage. Inspect all components for worn, cracked, or frayed cables or malfunctioning parts. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Event Description
Additional information: there was a five minute delay. Per the clinical review on (b)(6) 2016: right after the initiation of cardiopulmonary bypass (cpb) (before aortic cross-clamping), the perfusionist (ccp) noticed the centrifugal motor speed was erratic, even though he was not adjusting the speed knob. The speed was set by the ccp at about 2400 revolutions per minute (rpms), but the displayed speed was anywhere from 800 to about 1200 rpm. This dropped the arterial blood flow rate and the ccp stated he clamped the arterial line to prevent backflow. Then in a few seconds, the motor speed returned to 2400 rpm, but again in next seconds dropped and alternated between 800 to 1200 rpm. The ccp had a back-up system (control module, battery, motor, and flow sensor) in the pump room and he had a transporter bring the complete system to the operating room (o/r). The ccp removed the entire system from the base and replaced with the back-up. He powered up the system and moved the centrifugal pump head to the back-up motor. Cpb was re-initiated and motor speeds were able to be set at 2400 rpm and he was able to set the speed to his target rate. After the ccp was back on cpb, he attached the flow sensor (on new system) to the arterial line tubing. This delayed the start of cpb by about five minutes and there was a complete loss of blood flow for about 30 seconds during the change over. The case was completed successfully, without associated blood loss and no harm was observed.
 
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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 Key5347137
MDR Text Key35549846
Report Number1828100-2016-00004
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 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6379
Device Catalogue Number6379
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/1999
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number1828100-01/09/12-005-C

Patient Treatment Data
Date Received: 01/06/2016 Patient Sequence Number: 1
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