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 12/03/2014

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 twice.No message was observed on the central control monitor (ccm) or the roller pump display.The device was not changed out, as the roller pump had been 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.No issues observed with the arterial roller pump prior to cpb.During cpb, the arterial pump stopped twice without warning and without any error codes or messages.There were no safety issues (air, low level, or high pressure conditions) at the time of the pump stops.At time of the stops, the local display was still illuminated with no sign of loss of power to the pump.Handcranking was not done, as the pump was re-started quickly by simply touching of the forward button.There were no other issues observed during the procedure.The case was completed successfully, without delay and without associated blood loss.

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

The reported complaint was not confirmed.The pump was returned for evaluation and neither the product surveillance technician (pst) nor service repair technician (srt) could duplicate the complaint.The pump was operated overnight and was functioning the next morning, put in a cold chamber for two hours and operated for six hours with no stopping and internal components were inspected with no anomalies found.The srt replaced the membrane display as a precautionary measure.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: 4360667
• MDR Text Key: 5236119
• Report Number: 1828100-2014-01121
• 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?: Yes
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• 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?: Yes
• Date Device Manufactured: 06/01/2010
• 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