MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE)

Model Number 802018

Device Problems Failure to Sense (1559); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the flow module was not reading flow.There was a yellow light when it should be green.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.Per the clinical review on (b)(6) 2014: during priming of the cpb circuit, prior to cpb, the flow sensor was connected to a primed arterial line tube.There was no flow rate displayed on either the local display or the central control monitor (ccm).The perfusionist (ccp) confirmed the centrifugal pump head was spinning and a circuit pressure was being displayed, indicating flow was occuring.The flow module light emitting diode (led) was yellow.There were no error codes and no indication of system or motor issues.The ccp elected to bring in a stand-alone sarns centrifugal system and he clipped the flow sensor, from the stand-alone, to the arterial line of the cpb circuit.(b)(4) / mdr #1828100-2014-00994 clinical review continued: flow was displayed on the sarns centrifugal control module and the displayed flow was reasonable for the revolutions per minute (rpm) level of the motor.The ccp elected to use the sarns centrifugal control module to measure flow and the system-1 centrifugal control unit, with motor, was used to control the motor and display pump speed.These devices were used during cpb without issue and the case was completed successfully, without delay and without associated blood loss.There was no harm observed or reported.The manufacturer's fsr discovered after the procedure that the wrong perfusion screen was selected and boot-up and the screen selected did not have a flow module configured.The fsr configured a flow module and flow was measured and displayed without issue.

Manufacturer Narrative

The reported complaint was confirmed by the field service representative (fsr).Troubleshooting by the fsr, found a second perfusion screen had been created without the flow module programmed.This second screen was chosen inadvertently by the perfusionist on this case.The fsr tested the flow module in a different screen which included the flow module and it worked fine.The fsr then loaded the flow module into the other perfusion screen and the flow module worked as it should.The system-1 operated to manufacturer specifications and was returned to clinical use.The software data logs were received by the manufacturer on (b)(4) 2014 for further evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (HEART LUNG CONSOLE)
• 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: 4307571
• MDR Text Key: 5273492
• Report Number: 1828100-2014-00994
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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