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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 Back to Search Results
Model Number 16402
Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2017
Event Type  malfunction  
Manufacturer Narrative
As per perfusionist, the occlusion was set by dropping the tubing in the raceway, slowly occluding the tubing via the appropriate knob. Once the tubing was secured, he then clamped the negative side and turned on the roller head. If no negative pressure was sustained upon removal of the clamp, he proceeded to occlude the tubing with a partial tightening and then repeated until slight negative pressure was sustained and a slight "pop" from the tubing occurred upon removal of the clamp on negative side and had no problem setting the occlusion prior to the case. Also the perfusionist (ccp) add that the incident occurred at the end of the case, when the anesthesiologist was administering protamine, and they were about to shut off the roller head pumps. The surgical technician informed the ccp that the suction stopped so he proceeded to the pump and attempted to reinitiate the roller head. The roller head then proceeded to turn in rapid spurts and then stopped. The ccp turned the reostat down, and tried to start it again, and it merely repeated by turning in short spurts and then shutting down.
 
Manufacturer Narrative
(b)(4). As per the fsr, when troubleshooting the roller pump had stopped and displayed an overspeed error message shortly after the pump was turned on. The roller pump would speed up and slow down a couple of times before the error message was displayed. The fsr removed the printed circuit board assemblies (pcba) and reinstalled them, turned the flow knob to max and the pump functioned normally. He ran the pump for a half hour changing flow rates with no failures. The fsr deduced that there was a loose connection. The unit operated to the manufacturer's specifications. 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
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump stopped. 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. Per clinical review: the perfusionist had a vent or sucker pump on the heart lung machine (hlm) and it gave an overspeed error message during the bypass procedure. He proceeded to change the tubing over to a non-used roller pump and continued the case without issue. There was no delay in the surgical procedure, no blood loss nor harm to the patient. The overspeed message is a failure of the pump or the central processing unit (cpu) board. The field service representative (fsr) followed up with facility on the following day and did confirm a overspeed 1 error which is the failed motor. The fsr installed a physical back up roller pump on the hlm.
 
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Brand NameSARNS 8000 UNIVERSAL ROLLER PUMP
Type of DevicePUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key6962921
MDR Text Key247786455
Report Number1828100-2017-00480
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16402
Device Catalogue Number16402
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 Received11/01/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/19/2017 Patient Sequence Number: 1
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