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

Model Number 195215

Device Problems False Alarm (1013); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Upon receipt of the device, the user stated that during inspection of new level sensor, it gave false detection of liquid even when there was no liquid in reservoir.The issue was duplicated when bending load is added to the root cable of sensor sensing.This is considered an "out of box" failure.There was no patient involvement.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.During laboratory evaluation the product surveillance technician (pst) connected the level sensor to a level detect module that was assigned to a perfusion screen on a system 1 simulator.The pst attached the sensor¿s head to a fluid reservoir.The sensor was able to detect fluid and alert when fluid was absent but intermittently a ¿level not attached¿ message appeared on the ccm.The pst found that flexing the sensor¿s cable would cause the ¿level not attached¿ message to appear and disappear.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

(b)(4).The device was returned to the supplier for further analysis.The supplier confirmed a shielding wire was broken, and the signal from the sensor was weaker than expected and contained electrical noise.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: TERUMO 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5064608
• MDR Text Key: 25312382
• Report Number: 1828100-2015-00774
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 01/27/2016

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: Health Professional
• Device Model Number: 195215
• Device Catalogue Number: 195215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1