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 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the user facility, they use the prescribed gel and wait the recommended five minutes before attaching the level sensor to the mounting pad.Several mounting pads had popped off before they decided to not use them.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the mounting pads were popping off.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

The reported complaint was not verifiable.Diligence for part return and additional complaint information was unsuccessful.No product was returned for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.This is related to (b)(4) / mdr # 1828100-2018-00111.

• 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
• MDR Report Key: 7317914
• MDR Text Key: 101858805
• Report Number: 1828100-2018-00110
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K163531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• 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?: Yes
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC RESERVOIR