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

Model Number 164267

Device Problems Out-Of-Box Failure (2311); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The fsr replaced the drive motor.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.This complaint is related to (b)(4) / medwatch #1828100-2018-00323.

Event Description

It was reported that during field service installation of the device, the drive motor was causing the display on the centrifugal controller unit to intermittently blank out.There was no patient involvement.

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.

Manufacturer Narrative

The reported issue was confirmed.The service repair technician (srt) could not duplicate the reported complaint condition.The unit operated to manufacturer's specifications.Per data log analysis, while in a perfusion screen the central control monitor (ccm) reports the centrifugal pump missing at 2:13:11 pm, and returns at 2:13:52 pm.If the pump rebooted the display would have gone off as reported.No way to tell why the possible reboot occurred without the pump log for that time.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: 7626792
• MDR Text Key: 112003083
• Report Number: 1828100-2018-00324
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000458
• UDI-Public: (01)00886799000458(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: 10/01/2018

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: 164267
• Device Catalogue Number: 164267
• 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: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1