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

Model Number 816571

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The fsr replaced the display and the display cable.The unit operated to the manufacturer's specifications.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the local display on the roller pump would blank out intermittently.No other details regarding the nature of this event were provided.Per clinical review: the manufacturer's clinical specialist attempted to gather additional information regarding the incident the team had with their six inch roller pump on the heart lung machine (hlm), but no additional information was available at the time of this clinical review.It is not known when the occurrence was, but the field service representative (fsr) was able to repair the pump.What is currently known is that during a cpb procedure the local display of the roller pump would intermittently go blank.The perfusionist was able to use the central control monitor (ccm) controls to alter the flow as needed for the remainder of the procedure.This failure does not cause a delay in the surgical procedure.Additionally, this failure mode does not cause harm or blood loss.

Manufacturer Narrative

Updated block: d10.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician observed the display assembly to operate as intended throughout the evaluation.However, r1 and r10 transistors have a burned appearance and likely caused an intermittent failure of the display.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: 9878874
• MDR Text Key: 195139016
• Report Number: 1828100-2020-00140
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)170717
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• 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
• Report Date: 06/01/2020

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/26/2020; 05/20/2020
• Supplement Dates FDA Received: 04/17/2020; 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1