MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR ADVANC

Model Number 816571

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass procedure, when the pump operated with a flow rate of 0.7 l/min, it was not rotated at a constant speed.Then, an abnormal sound was heard and the pump did not stop.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

Evaluation is in progress, but not yet concluded.

Event Description

Per clinical review on january 9, 2017: noise and pulsing type behavior occurred with the arterial roller pump.This behavior can be seen if the occlusion of the roller pump is too tight and frequently messages (e.G.Underspeed and beltslip) will be posted.No messages were posted.According to the manufacturer's subsidiary, the behavior existed throughout cardiopulmonary bypass, but the pump did not stop and was able to be used without hand cranking or replacement.The procedure was completed successfully, without delay and without associated blood loss.There was no harm observed.The pump was removed from service after cardiopulmonary bypass was completed.

Manufacturer Narrative

The product surveillance technician (pst) observed that the pump to generate low humming noise when adjusted to optimal occlusion and louder humming noise and perceived pulsating while over occluded at 0.7 liter/minute.Louder humming noise and perceived pulsating is a normal known result of over occlusion.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: LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR ADVANC
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6230304
• MDR Text Key: 64366465
• Report Number: 1828100-2017-00010
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/26/2016
• Initial Date FDA Received: 01/06/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/02/2017; 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2008
• 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