MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 164267

Device Problems Corroded (1131); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that prior to use of the device for cardiopulmonary bypass (cpb) procedure, an "overspeed" error message was displayed.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 for a procedure on (b)(6) 2018, the perfusionist had an "overspeed" error on the heart lung machine (hlm).She checked to make sure that the disposable was seated correctly on the centrifugal motor, and checked all connections in the system, and all were in working order.The team changed out the hlm, and prepared to use another system for the procedure.The procedure was not delayed due to the overspeed error.There was no harm nor associated blood loss due to the issue.

Manufacturer Narrative

The reported complaint was confirmed.The returned motor assembly was determined to be not defective since it passed all the evaluations needed.However, the corrosions were seen in the motor controller pins of the associated complaint which then resulted to the reported issue.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 #1828100-2018-00090.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed the pump to function as intended throughout the evaluation.

• 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: 7280600
• MDR Text Key: 100557701
• Report Number: 1828100-2018-00082
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K163531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1