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 12/07/2018

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial pump stopped for 11 seconds.The pump was restarted and worked correctly.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) was not able to duplicate the issue.The pst observed the pump to function as intended; no pump stops during testing per known user technique.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) was not able to duplicate the reported complaint.He replaced the pod assembly as a precaution.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

Per data log analysis, on (b)(6) 2018 the arterial large roller pump speed was set to 4.247 liters per minute (l/min) at 10:04:37am.At 10:04:45 am, the stop button was pressed on the central control monitor (ccm) arterial pump icon.The pump was started again at 10:04:56 am from the local pump control (not the ccm).Most likely the stop button was accidently pressed on the ccm.

Event Description

Per clinical review: on (b)(6) 2018, the roller pump used in the arterial position had no issue prior to initiation of cardiopulmonary bypass (cpb) procedure.The team used a 1/2 arterial tubing as the boot in their raceway.During the procedure, the roller pump stopped forward flow.According to the information available, there was no visual or audible alarms that indicated a stoppage of the forward flow of the roller pump.The perfusion team was able to engage the start/stop button and come up to an appropriate forward flow for the remainder of the procedure.The stoppage of the pump was for a total of 11 seconds.There was no harm associated with the event.This incident did not delay the surgical procedure, and there was no blood loss due to the occurrence.The team exchanged the heart lung machine (hlm) after the case to investigate the incident.It was stated that the connections from the pump to the network interface card (nic) board were tight, but that the last preventative maintenance (pm) on this system was february 1, 2018.

• 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: 8184256
• MDR Text Key: 131006626
• Report Number: 1828100-2018-00654
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1