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

Model Number 816571

Device Problems Display or Visual Feedback Problem (1184); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.Per data log analysis, there were three pump stop events that occurred while the pump was running greater than 3 l/min.These are likely where "service pump" was displayed as per the clinical review.When a pump stops the portion of the display that displays flow will go blank.This is likely what was meant by display went blank.When a pump stops and displays "service pump" only the pump stop is logged.There is no way to tell from the log what caused the pump stop and the service pump message.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial roller pump stopped and the flow rate on the pump display went blank (no local controls).A "service pump" error message was displayed.The device was not changed out, as they continued to use the pump.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on 08-feb-2016: this was a pediatric case at (b)(6) and the patient was the size of an adult.A large roller pump was being used as the arterial pump and a 1/2" inner diameter (id) tubing was used.According to the perfusionist (ccp), there were no issues with setting occlusion and no other signs of problems during priming and preparation for cpb.About one minute into cpb at a blood flow rate of about 3.0 liters per minute (l/min), the arterial pump stopped without any audible warning and without any user intervention.According to the ccp, the pump was in the stop mode and the message "service pump" was posted on the local display.The ccp re-started the pump (by touching the start button on local display) in about 20 seconds.He was able to return to cpb at a flow rate of near 4.0 l/min.In about two to three minutes, the arterial roller pump again stopped, without any audible warning, and "service pump" was again displayed.The ccp re-started in less than five seconds and cpb was re-started with a flow rate of 4.0 l/min.About seven minutes later, the arterial pump again stopped without audible indication and again "service pump" was displayed.The pump again was re-started in a couple of seconds and no other issues with this pump occured for the remainder of the procedure.The ccp stated he had a back-up roller pump ready and in-place if needed.In summary, the arterial roller pump stopped three times within ten minutes and "service pump" was posted each time and the pump was able to be re-started each time.The case was completed successfully, and since the stops were brief, the procedure was not delayed.There was no associated blood loss and there was no harm observed.

Manufacturer Narrative

During the laboratory evaluation, the product surveillance technician (pst) could not duplicate the reported issue.Approximately 90 hours of run time under various conditions were performed.While running, all internal cabling, components and associated connectors were manipulated including the display ribbon cable.No trouble found.The product was sent to service for further evaluation.

Manufacturer Narrative

The reported complaint was confirmed by log analysis.The service repair technician (srt) observed the pump to operate as intended.He performed preventive maintenance (pm) inspection and verification/release test.The unit operated to manufacturer specifications and was returned to clinical use.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: 6 INCH ROLLER PUMP FOR ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
• 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: 5462986
• MDR Text Key: 39485479
• Report Number: 1828100-2016-00120
• 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
• Report Date: 06/03/2016

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-05/04/12-010-C
• Patient Sequence Number: 1