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

Model Number 874608

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

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

Per fsr, he reseated the real time clock (rtc) and memory card a few times getting the same results each time.He reinstalled the original rtc.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that after the installation of the device, the central control monitor (ccm) would not boot up and displayed red and gray lines.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) was unable to duplicate the reported complaint.The real time clock was inspected and installed in lab use only central control monitor (ccm) and observed to performed as intended throughout evaluation.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7578513
• MDR Text Key: 110457611
• Report Number: 1828100-2018-00296
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 874608
• Device Catalogue Number: 874608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1