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 Problems Failure To Adhere Or Bond (1031); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was not verifiable.The defective pads have been disposed of by the user facility.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

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pads were not sticking.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.Per clinical review: during a cpb procedure on (b)(6) 2018, the level sensor pad would not stick appropriately on their sorin/livanova inspire oxygenator, rounded integrated reservoir.The team went through four sensors before and during cpb to get one that adhered appropriately to sufficiently hold the level sensing cable, and have the system work to specifications.There was not a concern about either the cable or the level module.It is unsure if the team is waiting the instruction for use (ifu) described five minutes before they load their cable, and if they are placing the sensor pad on the labeled/sticker area on the rounded reservoir.The account is a long time user of the system and we have discussed the ifu on the steps top correctly engage the level sensing system.The incident did not delay the surgical procedure, and there was no blood loss or harm associated with the event.

• 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 (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7536527
• MDR Text Key: 109044376
• Report Number: 1828100-2018-00273
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2018
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Device Lot Number: 822508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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
• Treatment: SORIN/LIVENOVA INSPIRE OXYGENATOR