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

Model Number 816300

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the central control monitor (ccm) displayed a "disk boot failure, insert system disk and press enter" message.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Per the manufacturer's subsidiary, the unit's hard disk drive (hdd) had not been replaced.During laboratory analysis, the product surveillance technician (pst) observed the hard drive to function as intended throughout the evaluation.

Manufacturer Narrative

Evaluation is in progress but not yet concluded.

Manufacturer Narrative

Per the manufacturer's subsidiary, the service engineer replaced the hard drive printed circuit board (pcb).The suspect part will be returned to the manufacturer for evaluation.

Event Description

Additional information received indicated that there was no delay to the procedure.

• 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: 8164611
• MDR Text Key: 130492969
• Report Number: 1828100-2018-00643
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 12/12/2018; 12/19/2018; 02/06/2019
• Supplement Dates FDA Received: 01/04/2019; 01/11/2019; 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1