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

Model Number 16402

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) inspected the unit and confirmed the occlusion knob was difficult to adjust.The fsr regreased the occlusion knob.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 set-up of the device for a cardiopulmonary bypass (cpb) procedure, the pump occlusion was jammed, not working, spinning and not moving in and out.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), a ¿sticky substance¿ was found on the sliders of the roller pumps.This appears to not have been degraded grease from the main shaft/knob area.Cleaning of this area of the roller pump resolved the stiff operation of the occlusion mechanism.He re-greased occlusion knob.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 UNIVERSAL ROLLER PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6540521
• MDR Text Key: 74484069
• Report Number: 1828100-2017-00215
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/1999
• 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