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 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per log analysis, there are no indications of a problem in the log, the pump worked as designed and configured.The field service representative (fsr), could not verify the reported complaint.The perfusionist said that they were able to restart the pump after they had stopped by pressing pump start button.The fsr tested both pumps which ran without any unexpected stops.The cardioplegia pump is configured to stop when arterial pump stops on the system.Fsr checked operation of both roller pumps, no problems found, roller pump fans operating and connections are okay.The roller pump was found to be operating to terumo specifications and was returned to clinical use.This complaint is related to (b)(4)/ medwatch #1828100-2016-00816.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

It was reported that during use of the device for a cardiopulmonary bypass procedure, the arterial pump stopped abruptly without any alarm.The customer was able to restart it and continued to use it throughout the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: the arterial roller pump stopped twice during cpb without any alert / alarm / error messages to indicate a problem or safety event.Perfusionist stated the pump was able to be quickly re-started each time and the pump was used for the completion of the procedure.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

As per field service representative (fsr), the facility's biomed is terumo trained and does the in-house repairs for this hospital.The biomed has already inspected the unit.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

Corrected information: data log analysis confirmed that the pump stopped twice while running, but does not indicate why it stopped.

Manufacturer Narrative

The reported complaint was confirmed by data log analysis.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.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: 6203838
• MDR Text Key: 63622120
• Report Number: 1828100-2016-00817
• 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
• Report Date: 03/27/2017

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: 12/02/2016
• Initial Date FDA Received: 12/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2017; 03/03/2017; 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2009
• 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