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 Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the roller pump display flashed all green and did not boot up.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

(b)(4).The reported complaint was confirmed.The field service representative (fsr) performed preventive maintenance (pm) on the suspect roller pump and it would not boot-up, as the small display on the pump was flashing.The fsr replaced the driver board and the central processing unit (cpu).The unit operated to manufacturer specifications and was returned to clinical use.The suspect device was returned to the manufacturer for further evaluation.During laboratory evaluation, the product surveillance technician (pst) found the integrated circuit (ics) u1 and u2 on the cpu board were not fully seated into their sockets resulting in random numbers on an 8k pump test fixture¿s display.The driver/power board operated as designed.After fully seating ics u1 and u2, no further failures occurred.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a follow-up emdr 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: 5462812
• MDR Text Key: 39522673
• Report Number: 1828100-2016-00118
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• 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: 03/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2006
• 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