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

Model Number 801763

Device Problem Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) verified the reported complaint.He found in the service screen that one power supply was listed as "fail" and had no output voltage.He replaced both power supplies.The unit operated to the manufacturer's specifications.The suspect parts were returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, a "battery cannot be charged - full backup may not be available" message was displayed while the battery icon was green.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed one power supply to have the expected output of 24 volts, but the other power supply only had an output of six volts, which is not within specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Per clinical review: on 05-nov-2018, shortly after commencing a cardiopulmonary bypass (cpb) procedure, the perfusion team received a message in the message bar that stated the battery cannot be charged, and that full battery backup may not be available.The battery icon at this point was solid green.The team did not lose alternating current (ac) power during the case, so they were not concerned with the continued use of the device for the remainder of the procedure.There was no delay in the continuation of the surgical procedure.There was no blood loss or harm related to the occurrence.The manufacturer's field service representative (fsr) replaced both power supplies and the system since this event has worked according to specifications.

• 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: 8107483
• MDR Text Key: 129066497
• Report Number: 1828100-2018-00609
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)171108
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2019

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: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 11/28/2018; 01/15/2019
• Supplement Dates FDA Received: 12/16/2018; 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1