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

Model Number 806455

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.Per the user facility's perfusionist the occluder module was removed and reinserted.The error message was cleared but quickly reappeared.The unit was rebooted and the issue was resolved.Data logs were returned to the manufacturer on "04-may-1018".

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the occluder stopped working and displayed "venous occlude/service" error message.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During the laboratory analysis, the product surveillance technician (pst) observed a large amount of corrosion inside of the occluder head, interfering with the operation of the device.There were no venous/service error messages observed during the evaluation.

Manufacturer Narrative

The service repair technician (srt) observed the occluder's plunger to slightly move when the calibrate button was pressed, which was not enough to actually calibrate the occluder.Due to uneconomical costs of occluder repair, it will then be replaced with a new unit.Per data log analysis, the system log does not cover the event because the module info tab was left open which logs lots of information.The occlude log does show 2 "vmot current out of range (3328ma, 3362 ma) events.This will cause the occluder service alert as reported.While in the module info tab, the occlude vmot current was reading higher than normal at close to 3a.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: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7549430
• MDR Text Key: 109494815
• Report Number: 1828100-2018-00280
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2018

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: 806455
• Device Catalogue Number: 806455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/05/2018; 06/29/2018
• Supplement Dates FDA Received: 06/26/2018; 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1