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 Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Per the field service representative (fsr), after attempting to turn on the machine, there was a popping sound and smoke.The logs showed a power supply 2 (ps2) failure.Since the power supplies were an older version, she replaced both power supplies.She also replaced the power manager board and the batteries as a precautionary measure.The unit operated to the manufacturer's specifications.The suspect parts will be returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the batteries would not charge.As a result, an alternate device was employed.There was no delay in the surgical procedure.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Updated block: d10.Per the field service representative (fsr), the heart lung machine was taken out of service before use and no surgeries were cancelled or affected.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the reported issue.Several parts were received on this complaint.All parts were functionally acceptable except for one faulty power supply.When the power supply was tested the fans on the power supply could be seen starting and stopping and no discernible output could be measured.No further testing could be conducted on this power supply, as it is not functional.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
• MDR Report Key: 10286120
• MDR Text Key: 199690652
• Report Number: 1828100-2020-00266
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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: 07/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-06/05/2007-008-C
• Patient Sequence Number: 1