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 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4), pad, 3194 - adhesive.

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

Updated block: concomitant medical products.Per the manufacturer's territory manager, the pads were not mounted on a seam and the user facility waited to the recommended five minutes before attaching the level sensor.

Manufacturer Narrative

(b)(4).The reported complaint could not be confirmed.Additional parts returned were determined to be applicable to this complaint.During laboratory analysis, the product surveillance technician (pst) was not able to duplicate the reported issue.The mounting pads stay adhered to oxygenator throughout the three hour testing period.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.This complaint is related to (b)(4) / medwatch #1828100-2018-00068.

• 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: 7326768
• MDR Text Key: 102158020
• Report Number: 1828100-2018-00115
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2019
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Device Lot Number: 847342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC FUSION RESERVOIR