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

Model Number 801763

Device Problem Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

Per the field service representative (fsr), he tested the suspect unit and could not verify the reported complaint.The unit operated to the manufacturer's specification.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the battery icon of the unit was red and not fully charged.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during set up for the cpb procedure on (b)(6) 2018, the team noticed that the system had a red icon on the battery, and the system was not fully charged.They opted to commence cpb, for they were not concerned about not having full battery back up if they were to lose alternating current (ac) power.The perfusionist stated that all systems were working well, and they felt comfortable that the system would fully charge during the procedure.There was no blood loss, harm or delay in continuation of the procedure due to the heart-lung machine (hlm) not being fully charged when the team commenced cpb.

Manufacturer Narrative

The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

Per data log analysis, the system is powered off from (b)(6) 2018 until (b)(6) 2018.When the system is powered up on (b)(6) 2018 the battery capacity is reported as empty and the battery is being charged in bulk charge.Eventually the battery is fully charged and the charger switches to float charge.There is no indication of a problem in the log.Issues with the battery icon would likely not cause anything to be logged.The state of the battery is questionable since the system was left powered off for almost two months.

• 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: 8094093
• MDR Text Key: 128269709
• Report Number: 1828100-2018-00602
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-03/13/12-004-C
• Patient Sequence Number: 1