MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO 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 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the level sensor pad easily comes off from the reservoir.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 the clinical summary on (b)(6)-2015: information was received from the subsidiary site via email.A mera hpo-23rhf-cp oxygenator and reservoir was used during the procedure.In review of the reservoir pictures, there are rounded sections of the reservoir and this may have resulted in sensor pads not sticking adequately.Another potential issue is the age of the pad, and age can lead to performance issues regarding the pad adhesive.In the end, a pad was able to be adhered adequately to the reservoir during prime.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.During the laboratory evaluation, the product surveillance technician (pst) observed the two returned level sensor pads stayed firmly in place on an oxygenator with level sensors mounted to the pads.The sensors were affixed to the reservoir per operators manual instructions.Lab use level sensors were then attached to the mounting pads.The pads remained adhered to the reservoir, and no separation was noted.Level sensors were monitored with the system 1, which issued no ¿not attached¿ messages during a six hour period.Subsidiary correspondence with the customer indicates the customer is following operators manual for affixing mounting pads.Mounting pads had an expiration date of 09jul2015.Customer used the mounting pads on 02sep2015, nearly two months after the expiration date.The mounting pads can exhibit degraded adhesive performance past their expiration date.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: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5194597
• MDR Text Key: 30368612
• Report Number: 1828100-2015-00931
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2015
• Device Model Number: 195240
• Device Catalogue Number: 195240
• Device Lot Number: 145601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1