MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP

Model Number 16402

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.On 2-nov-2015, the ccp showed the field service representative (fsr) several cell phone videos showing the roller pump running and making a thumping (grinding) noise.The fsr watched the videos on the ccp's cell phone, but was not able to hear the thumping/grinding noise because of background noise on the video.The videos show the roller pump is not running smoothly, it appears to be hesitating as it runs.The fsr tested the roller pump with dual 1/4 inch tubing installed, no unusual noises were observed.This is a repeat complaint of the same roller pump and when tested the fsr could not verify the issue when tested.The fsr was able to have a loaner pump sent to the user facility.The fsr installed the loaner pump and tested operation satisfactory.The unit operated to manufacturer specifications and was returned to clinical use.The suspect device was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, the roller pump was making a thumping noise while running.The roller pump was not running smoothly, it appears to be hesitating as it runs as if it was in pulsatile mode, but there is no pulse module on this system.The roller pump was in the sucker position.The device was not changed out, as they kept using the pump.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on 13-nov-2015: the perfusionist (ccp) stated that during cardiopulmonary bypass, the roller pump that was being used in the sucker position, was making a grinding or thumping noise.Associated with the noise appeared to be a "tugging" of the roller, as if it were in a pulsatile mode.When she placed her hand on the side of the pump she could feel a grinding.The ccp said that the occlusion was not jammed and with the roller pump fully unoccluded, it still manifested the same behavior.The ccp stated that there was no impact to the patient.She did not change the roller pump out.The ccp added that she feared it would lose function, but it never did.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) was able to duplicate the thumping noise and jerky rotations from the roller pump motor.After approximately two hours, a thumping noise was heard from the pump¿s motor and the motor¿s rotations would hesitate once every rotation of the motor shaft, causing a jerking motion of the guts.When rotated by hand, the pump¿s guts turned smoothly.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS 8000 PERFUSION SYSTEM
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP
• 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 Key: 5242284
• MDR Text Key: 32201974
• Report Number: 1828100-2015-00987
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915183
• 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: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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