MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS 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 Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per sales representative, hospital had two visits from field service but the issue still re-occurred.They are asking if they can ship the entire system 1 for repair.Additional diligence confirmed the pump stops occurred during priming and after the procedure.This complaint is related to (b)(4)/ medwatch #1828100-2017-00013.This complaint is related to (b)(4)/ medwatch #1828100-2017-00015.

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass procedure, the user facility reported that the large roller pump stopped.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 reported.Per clinical review, the pump had stopped earlier in the day when a perfusion circuit was being primed and prepared for cardiopulmonary bypass.It stopped, without user intervention, and a service pump message was posted on the local pump display.It could be re-started with local pump controls, but the perfusionist elected to not use the pump during the procedure and totally new perfusion system was used during the procedure.After the procedure was completed, the perfusionist was trying to duplicate the pump stop, with service pump messaging.The perfusionist started the pump and ran the pump at about 4-5 l / min and the pump did stop and the service pump message was posted on the local display.The perfusionist was able to duplicate the pump stop as observed during prime.This pump was not used during the procedure.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint.He operated the pump for approximately 180 hours with no pump jam and no "service pump" message observed.Per data log analysis, no actual indications of a problem are found in the log files.The large roller pump art did stop three times, but there is currently no way to tell from the log if service pump was displayed.The art pump only had 1 configured safety connection to stop on air bubble detection.

Manufacturer Narrative

The reported complaint was confirmed via data log analysis.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 SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6234443
• MDR Text Key: 64606585
• Report Number: 1828100-2017-00015
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2017

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: 01/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/09/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/03/2017; 05/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1