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 APS 1

Model Number 801041

Device Problems Inaccurate Flow Rate (1249); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.

Event Description

It was reported that during cardiopulmonary bypass procedure, there was a roller pump belt slip error and the flow rate is higher than what is displayed.The alarm went off twice.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: 28-oct-2016: the responsible perfusionist during the procedure responded.Shortly after initiating cpb, the calculated flow rate on the arterial roller pump dropped to about 3.0 l/min, but according to the perfusionist the pump was visibly running at a higher flow rate and other indicators such as patient arterial pressure and arterial line circuit pressure indicated a higher than 3.0 l/min flow.In addition, during this period, the message beltslip was flashing on the local pump display.The perfusionist attempted to correct the issue by decreasing and increasing the pump speed but the behavior continued for about 30 seconds.After about 30 seconds, the beltslip message disappeared and the pump behaved per usual case.There were no mitigations to address the behavior and the pump was used without issue for the rest of the case.It was debated the occlusion may have been tight, but according to the perfusion team the occlusion was set per their normal practice.The occlusion was set by pressure decay method and the pressure dropped 1 mmhg / second at a circuit pressure of 200 - 200 mmhg.This method requires that during prime, the arterial line pressure is raised by clamping the tubing and raising the pressure to a range of 200 - 220 mmhg.The pump is stopped and the occlusion is adjusted for the above mentioned drop.This method of setting occlusion is not described in the aps-1 operator manual and has not been tested or validated at terumo.Some users do and have used this method (pressure decay) for setting occlusion, but they develop their own procedure.As i have heard from other users that practice this procedure, the 1mmhg drop per second is tighter than most utilize.In my clinical opinion, as the pump was used to complete the procedure without issue (after the first seconds) and beltslip was displayed.This pump behaved like it was over occluded and after the tubing was warmed up the behavior corrected itself.The procedure was completed successfully, without delay and without associated blood loss and no harm was observed.The pump is being returned and will be evaluated in (b)(4) lab.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed an error message "underspeed" then 'belt slip" message began to appear on pump display only when pump occlusion was adjusted to 70 clicks past optimal occlusion.The pst tested the pump for belt slip error condition with pump jam test fixture and observed pump to generate 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.

Manufacturer Narrative

Per data logs analysis, on (b)(6) 2016 the large roller pump reported underspeed (belt slip) twice as reported.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.The service repair technician (srt) could not duplicate the reported complaint.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 manufacturer's clinical services provided he provided proper instructions on how to use the product to the user.

• 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 SYSTEM CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6081046
• MDR Text Key: 59563608
• Report Number: 1828100-2016-00714
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/02/2017

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: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 06/08/2017; 09/29/2017
• Supplement Dates FDA Received: 12/09/2016; 01/27/2017; 02/24/2017; 06/30/2017; 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2003
• 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