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 801046

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The circuit was already broken down.This issue did not affect the patient, everything was already completed.On (b)(6) 2015 per the sales representative (sr): all four roller heads are working, the centrifugal control module (ccm) has power and is working, centrifugal motor is working (when tried with back-up delphin).The sr spoke with the manufacturer technical support and it was determined that a loaner ccm would be the best option.On (b)(6) 2015 per the ccp: "the incident occurred sometime after 1:00pm on (b)(6) 2015.We had already come off bypass and the cannulas were already taken out, so the pump was not needed at the time.There was no blood loss as a result.The ccm quit without any warning.The motor was not running at the time and the system-1 did not lose power.The ccp noticed it was not working as he was about to power the system-1 down.It never came back on regardless of restarting the system-1.Upon restarting the system-1, the centrifugal pump was not detected and appeared as a question mark on the perfusion screen.The sr came in this morning with a new centrifugal control module.We swapped it for the broken one, downloaded the system log, and he has both the broken module and the data disc with the system log in his possession.Currently, our system-1 is in working order." during laboratory evaluation the complaint was duplicated.The product surveillance technician (pst) connected the ccm to system-1 power supply and powered on.The pst observed no display on pump module.He disassembled the ccm and inspected all connections.All connectors have firm robust connections.The pst reapplied power to the ccm and observed no display and no power.He powered off device under test (dut) ccm.The pst determined that the graphics driver board and generic board were the cause of the problem.

Event Description

After use of the device for a cardiopulmonary bypass procedure, when they came off pump and decannulated, the perfusionist (ccp) looked over and the system was dead (would not turn back on).There were no reported adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.Per the log analysis on (b)(6) 2015 at 1:16:45 pm, while a perfusion screen is opened the ccm reports "err pod operational status timeout".Most likely it was the arterial centrifugal pump as reported.At 1:18:54 pm the perfusion screen is exited and the system is power cycled.When a perfusion screen is opened the arterial centrifugal pump is no longer detected.This will cause a '?' on the pump icon as reported.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.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

This complaint is related to medwatch:1828100-2015-00818.No additional action will be taken at this time.

• 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: 4957466
• MDR Text Key: 23234297
• Report Number: 1828100-2015-00655
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801046
• Device Catalogue Number: 801046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-06/05/2007-011-C
• Patient Sequence Number: 1