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

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

(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.

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.

• Brand Name: SARNS 8000 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, 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 Key: 6962921
• MDR Text Key: 90699953
• Report Number: 1828100-2017-00480
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 11/01/2017
• Supplement Dates FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention