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

Model Number 16402

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer will not be returning the unit as they are purchasing new units.This complaint is related to (b)(4) / medwatch #1828100-2017-00040.

Event Description

After use of the device for a cardiopulmonary bypass (cpb) procedure, the user reported that the roller pump's display went blank and reset itself.There were no reported adverse consequences to the patient.Per clinical review, according to the perfusionist, after cpb had been completed, she was recirculating the remaining blood in the cpb circuit with the arterial pump and a message was posted on the pump (fail 4).She continued to use the pump to recirculate the remaining blood and in a few minutes the pump display went blank.The pump continued to function (turn) for a few seconds but then reset and the pump stopped during the reset.Since this occurred after cpb, there was no delay in the surgical procedure.The pump was taken out of service after the procedure was completed.There were no issues or impact during cpb.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was not confirmed.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 P
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6282574
• MDR Text Key: 66221903
• Report Number: 1828100-2017-00041
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• 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: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2007
• 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