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

Model Number 802100

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed by the product surveillance technician (pst) as per laboratory report.The pst observed blank screen at boot up and inaccurate touch screen response.Replacement of customer inverter board and customer touch screen restored central control monitor (ccm) functionality.The device was sent to service to be brought to manufacturer's specifications before returning to clinical use.This complaint is related to medwatch #1828100-2016-00653.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 routine testing of the device at the service center, the senior quality assurance technician found that the central control monitor (ccm) has a defective touch screen.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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6132017
• MDR Text Key: 61403583
• Report Number: 1828100-2016-00767
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• 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: 01/27/2017

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: Other
• Device Model Number: 802100
• Device Catalogue Number: 802100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-06/05/2007-005-C
• Patient Sequence Number: 1