MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 802114

Device Problems Failure to Sense (1559); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As per field service representative (fsr), the reported issue was resolved before the case started.The fsr visited the hospital and verified there were no issues with the temperature module.The temperature module was measuring arterial temperature on the red channel and venous temperature on the blue channel.The system was set up with a connected dry circuit and both channels were reading temperature.Both channels of the temperature module were tested with the probes and no issues were found.The alarms functioned as well.The device was operating within 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.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the new arterial probe had to be disconnected/connected a couple of times before the temperature registered.Once registered, it worked without issue.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6536632
• MDR Text Key: 74409931
• Report Number: 1828100-2017-00210
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802114
• Device Catalogue Number: 802114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2009
• 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
• Treatment: TEMPERATURE PROBE