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 Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The user facility's biomed discovered the issue during testing of the device.

Event Description

It was reported that during the use of the device for a non-clinical activity, the unit would shut down.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, on (b)(6) 2018 a perfusion screen is opened at 06:31:14 am.On 07:37:28 large roller pump is started; 07:42:09 the pump is stopped when the perfusion screen is exited; 07:46:14 perfusion screen is opened; 07:46:31 the pump is started; 07:47:20 the pump is stopped and started; 07:49:41 the pump is stopped; 07:49:49 the pump is started; 07:54:29 the pump is stopped; 07:59:26 the pump is started; 12:19:15 the pump is stopped when the perfusion screen is exited.There is nothing unusual in the log.The pump stops look like the start/stop button was pressed.No way to tell from the log if the start/stop button was actually pressed.There is no indication of a shut down.It is possible the display went off without logging anything.The service repair technician (srt) was unable to 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

During laboratory analysis, the product surveillance technician (pst) observed the pump to function as intended throughout the evaluation.

• 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: 7293067
• MDR Text Key: 101120945
• Report Number: 1828100-2018-00095
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K131618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/05/2018

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: 02/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 02/22/2018; 04/04/2018; 08/29/2018
• Supplement Dates FDA Received: 03/19/2018; 04/24/2018; 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1