MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (ROLLER PUMP)

Model Number 816571

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial roller pump stopped working randomly during the procedure.There was no message on central control monitor (ccm) or pump display.The device was not changed out, as the pump was restarted by pressing button on the pump local control.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2014: there were no issues observed during set-up and preparation of the cpb circuit.During cpb, the clinical team observed that the arterial roller pump had stopped.There was no loss of power observed (no blanking of the local display) and there were no indications of alert/alarm conditions that could have triggered a pump stop.The pump was found in the stop mode and the perfusionist (ccp) touched the start button and the arterial roller pump was able to be re-started without issue.The pump was off for just a few seconds and there was no handcranking required.There no other issues with the arterial roller pump the remainder of the procedure.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

Software data logs were received by the manufacturer on (b)(4) 2014 for further evaluation.Data logs confirm the stop and start of the roller pump.

Manufacturer Narrative

The reported complaint could not be duplicated during laboratory evaluation.The product surveillance technician (pst) observed the roller pump to function properly with no stopping throughout the evaluation.The roller pump was sent to service for further evaluation.

Manufacturer Narrative

Updated: evaluation codes.The reported complaint was confirmed.Per data log analysis, this roller pump was not configured to the perfusion screen and was used as a stand alone pump.The pump logs show the pump was stopped but from local control, no problems are observed.The service repair technician (srt) could not duplicate the reported issue.As a precautionary measure the srt replaced the membrane display.No additional action will be taken at this time.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (ROLLER PUMP)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4360668
• MDR Text Key: 5118289
• Report Number: 1828100-2014-01090
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2015

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: 07/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/22/2015; 09/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1