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 Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the pump spontaneously restarted multiple times.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

Per data log analysis, on (b)(6) 2018 at 23:39:26, a perfusion screen is opened.23:40:59 pump is started on (b)(6) 2018.00:04:06 air detected alarm stops pump.00:04:13 pump is started.00:19:09 air detected alarm stops pump.00:19:22 pump is started.04:16:03 pump is stopped.04:16:28 pump is started - stopped - started - stopped - started.07:26:56 lid is opened - closed - opened - closed.07:52:07 pump is stopped and perfusion screen is exited.There is nothing unusual in the log on any date.On the reported complaint date there were two air detected alarms that stopped the pump.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed no spontaneous restarts and the pump functioned as intended.The cable that was used with the pump was not sent back for evaluation.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) was not able to duplicate the reported complaint.The unit operated to the manufacturer's specifications.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

Evaluation is in progress, but not yet concluded.

• 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: 8161173
• MDR Text Key: 130487908
• Report Number: 1828100-2018-00638
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2019

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: 12/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 12/17/2018; 02/04/2019; 04/05/2019; 05/13/2019
• Supplement Dates FDA Received: 01/11/2019; 03/01/2019; 04/26/2019; 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1