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

Model Number 801763

Device Problem Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.The field service representative (fsr) replaced the batteries and unit checked okay.Performed battery back-up test and the unit never recovered to full battery charge status.The fsr downloaded the data logs, installed a new power manager board, updated the software to version 1.70 and the issue was corrected.The fsr performed all checks and alignments.The unit operated to manufacturer specifications and was returned to clinical use.The suspect part was returned to the manufacturer for further evaluation.When the user unplugged the system, "zero" minutes were displayed on the central control monitor (ccm) battery icon, there was no time lag between unplugged and shutdown, this system was not a back-up unit, they did observe a warning before the system shut down, they did check the aux tab for messages related to battery back-up, they do fully charge the battery at least once a month, they do not fully discharge the batteries and power supply 1 (ps1) and ps2 showed within specifications.During the laboratory evaluation, the reported issue was corroborated.The device under test (dut) initially switched to battery power but premature battery shutdown occurred 15 seconds after switching to battery power.The product surveillance technician (pst) determined the cause was an open resistor r186.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 procedure, the perfusion system failed to switch over to battery power.The device was not changed out, as they plugged the system in and continued to use.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• Brand Name: TERUMO 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5922351
• MDR Text Key: 54418740
• Report Number: 1828100-2016-00594
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151349
• 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: 09/01/2016

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: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2006
• 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