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

Model Number 802110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) did preventive maintenance (pm) on the unit and the unit operated to the manufacturer's specifications.This complaint is related to (b)(4) / medwatch #1828100-2017-00482.This complaint is related to (b)(4) / medwatch #1828100-2017-00483.

Event Description

It was reported that during log analysis of the device, the air bubble detector (abd) was intermittently reporting an "8v power supply error" and "entering broken mode 56" error.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Data logs were obtained by the field service representative (fsr) while performing preventive maintenance (pm).The logs were reviewed for identified error messages.8v target events were found and referred to the manufacturer's technical (tech) support.Tech support reviewed the logs and determined that this event was related to an 8v target event.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
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6966133
• MDR Text Key: 90770083
• Report Number: 1828100-2017-00484
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 802110
• Device Catalogue Number: 802110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1