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

Model Number 195240

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As per the manufacturer's sales manager, the level sensors were being applied to a flat surface with the prescribed gel.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pads would not stick.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

(b)(4).The reported complaint could not be confirmed.During laboratory analysis, the product surveillance technician (pst), observed the mounting pads to adhere to the oxygenator as intended.Five of the 14 mounting pads received were tested as the protective covering was removed from the self-adhesive tape backing on the others so it was not clear if they had been used.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

Evaluation is in progress, but not yet concluded.

• 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 Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7263401
• MDR Text Key: 100044059
• Report Number: 1828100-2018-00068
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1