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

Model Number 816571

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Per the user facility's perfusionist, an "underspeed", "pump jam" and "pump error" were all displayed.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the unit displayed multiple error messages.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

During laboratory analysis, the product surveillance technician (pst) observed the pump to function properly when set to optimal occlusion setting.The pump did produce "under-speed" and "pump jam" error messages during extreme occlusion, which was an expected result.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b))6) 2018 the large roller pump logs "belt slip jam status = true", "underspeed (head < demand)", and then eventually "motor fault" as reported.Each of these events occur multiple times.This is an indication of an internal hardware issue with the pump.The service repair technician (srt) was unable to duplicate the reported complaint.The pump operated as intended when set to optimal occlusion settings.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
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8008769
• MDR Text Key: 125110372
• Report Number: 1828100-2018-00560
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)180213
• Combination Product (y/n): N
• PMA/PMN Number: K131618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2018

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: 10/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/26/2018
• Supplement Dates Manufacturer Received: 11/06/2018; 12/11/2018
• Supplement Dates FDA Received: 11/26/2018; 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1