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 Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's subsidiary, the pump was replaced.Data software logs were returned to the manufacturer on 18-dec-2018.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the pump being used in the arterial position stopped multiple times.Once stopped, the pump was turned back on and worked properly.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.The user facility has declined to return the pump, so no evaluation can be done.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

As per manufacturer's subsidiary, the pump is not going to be returned because the user facility wants to continue to use it after cleaning and inspection.Per data log analysis, on (b)(6) 2018: 10:58:19 arterial pump started, speed set to 3.203 l/min; 10:58:56 pump speed set to 3.509 l/min; 10:59:21 pump speed set to 3.635 l/min; 11:31:28 pump speed set to 3.653 l/min; 11:34:55 pump speed set to 3.671 l/min 11:49:06 pump speed set to 3.689 l/min;; 13:25:10 pump speed set to 3.383 l/min; 13:28:32 pump speed set to 0 l/min; 13:35:06 pump speed set to 0.233 l/min and back to 0 l/min; 13:38:36 pump speed set to 3.851 l/min; 13:47:26 pump speed set to 3.527 l/min; 13:49:03 pump speed reduced to 0.797 l/min and back to 3.750 l/min; 13:49:56 pump speed set to 3.475 l/min; 15:51:11 pump speed reduced to 1.810 l/min and back to 3.846 l/min; 16:31:16 pump speed reduced to 0 l/min; 16:31:50 pump speed increased to 1.187 l/min and back to 0 l/min; 16:33:20 pump speed increased to 0.827 l/min and back to 0 l/min; 16:42:27 pump speed increased and set back to 0 l/min several times; 16:56:01 arterial pump stopped.Pump speed was set to 0 multiple times.There is no indication of a problem in the log.

Event Description

Per clinical review: on (b)(6) 2018, the clinicians noticed that the arterial roller pump stopped twice without a visual or audible notice.The roller pump had no issue with start up and priming of the circuitry.During cardiopulmonary bypass (cpb) the unit stopped without notice twice, and the clinical team was able to reengage the start/stop button and resume forward flow promptly during both instances.The pump functioned normally for the remainder of the procedure.After the procedure, the team looked at the connection of the arterial roller pump to the network interface card (nic) board and that was confirmed to be tight and of no concern.The clinicians either used a 1/2 inch or 3/8 inch silastic tubing as their arterial boot within the roller pump for their procedures.The last preventive maintenance (pm) on this heart-lung machine (hlm) according to the information available was in july of 2018.This pump did not delay the surgical procedure.There was no harm or blood loss associated with the event.

• 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: 8189355
• MDR Text Key: 131339591
• Report Number: 1828100-2018-00663
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1