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

Model Number 195215

Device Problems False Alarm (1013); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, that during inspection, the yellow level sensor was false alarming.No problem was confirmed in attached state to the reservoir.The user suspect internal disconnection of the sensor.As a result, an alternative device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

This complaint is related to mdr #1828100-2015-00573.Software data logs were returned to the manufacturer on 06/28/2015 for further evaluation.Per the subsidiary site, the reported issue was an out of box failure which occurred during set-up.There was no delay and the product was changed out.There was no harm or blood loss due to problem.

Manufacturer Narrative

The reported complaint was confirmed.Data log analysis demonstrates there were several coupled/uncoupled/disconnected messages in the logs.This can be caused by improper coupling, mounting the sensor over an irregularity, or a bad sensor.Logs were not able to determine these factors.Correspondence with the manufacturing engineering center (mec) indicates that the customer is not returning the level sensor.Mec stated they examined the sensor¿s cabling via x-ray and did not see breakage.Script answers do not indicate an issue.The mounting pads were allowed to adhere for over the five minutes minimum recommendation and the proper gel was used in coupling the sensor to the reservoir.The sensors were reported to be mounted in an area free of obstructions, such as labeling or support ribs.No additional action will be taken at this time.

• 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: 4905127
• MDR Text Key: 6835108
• Report Number: 1828100-2015-00572
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,company repres
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 195215
• Device Catalogue Number: 195215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2015
• Initial Date FDA Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• 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