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 Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per user facility's biomedical technician, the issue was discovered when the unit was plugged in to be charged.This is a back-up unit and has not been used clinically in several years.The field service representative (fsr) verified the reported complaint.He replaced the right side network interface card (nic) power cable and the problem remained.He then replaced the power manager and the issue was resolved.The unit operated to the manufacturer's specifications.The suspect parts are being returned to the manufacturer for further evaluation.

Event Description

It was reported that during the use of the device for a non-clinical activity, there was a red "x" displayed on the central control monitor (ccm) for the roller pump.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) found no problem with the returned power manager board or the network interface card (nic) power cable.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 on (b)(6) 2017, both roller pumps were reporting "5v supply voltage test failure" events.This indicates the 5 volts (v) fell below 4.8v.This will cause an alarm and a red "x" on the pump icons as reported.

• 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
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7133234
• MDR Text Key: 95814783
• Report Number: 1828100-2017-00584
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• 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,Followup,Followup,Followup
• Report Date: 04/06/2018

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: 12/18/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2006
• 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