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 Type  malfunction  

Manufacturer Narrative

No consequences or impact to patient.Failure to adhere or bond.Out-of-box failure.Component code: adhesive.Per the user facility's perfusionist, several mounting pads were used as they kept separating between the level sensor pad adhesive and the ridged portion of the level sensor pad.This has occurred several different times.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the level sensor pads were coming off and triggered the level detector alarm.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss and no adverse event reported.Per clinical review: the perfusionist does not have an exact date of occurrence with the level sensor pads popping off the reservoir, but has stated that in the last seven months this issue has occurred about once every three weeks.The team has their system set up to just use the red alarm level sensor pad and cable, and it is set up to just alert the perfusionist, not to intervene to stop the roller pump.This issue has occurred on both the rx05, and rx15 oxygenator.She does state that she puts the level sensor pad on the graduated label on the front of the reservoir, and we have discussed the need to put it on a non-label area on the reservoir.According to the information available, she has waited the five minutes to attach the sensor cable, prior to bypass, but when she is on bypass and the level sensor pad disconnects from the reservoir, there is an urgent need to re-attach it or adhere a new one, so the five minutes is not feasible.This 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.Per the user facility's perfusionist, the defective pads were disposed of.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: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7487760
• MDR Text Key: 107571203
• Report Number: 1828100-2018-00241
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• 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,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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