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 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pad popped multiple times.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 set up, during circulatory arrest and during the rewarming phase of bypass the perfusionist had the level sensor pad disconnect from the reservoir.The first pad she did not wait the five minutes to load the cable.After she replaced the first one with another pad, she did wait the five minutes before placing the sensor on the reservoir.The following two she did not wait the five minutes, for she was on cpb and felt that it was more of an urgent matter to get the level detection system to work.The team was using a fx15 reservoir for this procedure and was only using the alarm cable.She does place her pads on the label of the graduated volumes.I suggested to her to place pads on a non-label portion of the reservoir, and if needed cut the wings of the pad to enable it to stick better on a non-labeled area on the fx15.The team has their heart lung machine (hlm) to just give the perfusionist a notification if the level goes below the set point, therefore this incident did not stop a pump.The incident did not delay the continuation of the surgical procedure.There was no blood loss or harm associated with the event.

Manufacturer Narrative

The reported complaint was confirmed through the clinical review from the manufacturer's clinical specialist.Multiple diligence attempts were unsuccessful for part return.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: 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: 7365241
• MDR Text Key: 103554343
• Report Number: 1828100-2018-00148
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• 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
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2019
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Device Lot Number: 845957
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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