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

Model Number 816571

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the roller pump had displayed "over speed belt" error.No other details regarding the nature of this event were provided.Diligence attempts are still ongoing in obtaining the surgery related questions.

Manufacturer Narrative

(b)(4).During laboratory analysis, the product surveillance technician (pst) observed a "beltslip" to appear on pump display only when pump occlusion was adjusted to 70 clicks past optimal occlusion.The pump was tested for belt slip error condition with pump jam test fixture and observed that the pump generated expected results.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

Additional information received indicated that the issue occurred during set-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

The reported complaint was confirmed.The service repair technician (srt) observed the motor encoder wheel to be too far down on the motor shaft.Upon removal of the encoder wheel there were metal shavings on the encoder sensor, as well as gouges in the motor retaining washer due to the encoder wheel sitting too low on the shaft.This is the likely cause of the underspeed error message.The product will be sent to service to be brought to manufacturer¿s 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.

Manufacturer Narrative

The reported complaint was confirmed.After further information was obtained from the data logs and supplemented by the sample evaluation the incorrect speed was most likely an underspeed error message, not an overspeed as reported.Per data log analysis on 22-feb-2018, the complaint indicates the problem occurred on (b)(6) 2017, but the pump was not used on that date.The log shows the issue occurred on (b)(6) 2017.On (b)(6) 2017 the pump stops and reports "belt slip jam status = true".The pump is started and four seconds later.Reports "underspeed (head < demand)".The pump.Reports "underspeed (head < demand)" one more time before the perfusion screen is closed.These events would likely cause an underspeed (not overspeed) and/or belt slip, pump jam errors.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 APS 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6701345
• MDR Text Key: 79812317
• Report Number: 1828100-2017-00301
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131618
• 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,Followup,Followup
• Report Date: 04/12/2018

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: 07/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 07/13/2017; 02/22/2018; 03/21/2018
• Supplement Dates FDA Received: 08/07/2017; 03/19/2018; 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2008
• 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