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

Model Number 816572

Device Problems Erratic or Intermittent Display (1182); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Per fsr the controller could not be controlled through the central control monitor (ccm).He replaced the controller.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during field service installation of the device, the display on the centrifugal controller unit would intermittently turn on and off by itself.There was no patient involvement.

Manufacturer Narrative

The reported issue was confirmed.Per data log analysis, there were six occurrences of logging stopping followed by a power up.This would cause the display to be off and lose control of central control monitor (ccm).There were no indication of the cause but it could be an intermittent cable issue.The service repair technician (srt) was unable to duplicate the reported complaint.He replaced the display-to-board cable, printed circuit board assembly and the small graphics display as a precaution and a possible cause of the reported issue.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

Additional information from the field service representative (fsr): the display was blank on the centrifugal, took centrifugal apart to checked the cables.They re-connected display cable, and re-installed display which came on.The drive motor was then connected and the display went blank again.The system was rebooted and the display came back on.The fsr replaced the dive motor and the centrifugal controller.The unit operated to the manufacturer's specifications.The product surveillance technician (pst) observed that the centrifugal drive motor and centrifugal controller to function properly during evaluation.The unit operated to the manufacturer's specifications.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: 7626789
• MDR Text Key: 112002302
• Report Number: 1828100-2018-00323
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001387
• UDI-Public: (01)00886799001387(11)180404
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 816572
• Device Catalogue Number: 816572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1