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

Model Number 802112

Device Problems Out-Of-Box Failure (2311); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) confirmed the complaint.He found the pressure module was not fully seated.He pulled the module and reseated it.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.

Event Description

It was reported that during the use of the device for a non-clinical activity, the pressure pod was causing a "?" to be displayed on the unit.There was no patient involvement.

• 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: 7526190
• MDR Text Key: 108737291
• Report Number: 1828100-2018-00264
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000724
• UDI-Public: (01)00886799000724(11)180227
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

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: 802112
• Device Catalogue Number: 802112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• 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