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

Model Number 802100

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00453.The reported complaint was confirmed.The pst observed the touch screen to function only in certain areas of the screen.Exterior inspection revealed no signs of abuse or damage.Interior inspection revealed no signs of ingress or tampering.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.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

The product surveillance technician (pst) reported that during routine testing of the device at the service center for emdr #1828100-2016-00453, the touch screen of the central control monitor (ccm) was inoperable.There was no patient involvement.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: CCONSOLE, 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5790200
• MDR Text Key: 50177886
• Report Number: 1828100-2016-00499
• 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
• Report Date: 07/13/2016

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: 06/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2003
• 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