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

Model Number 801763

Device Problem Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The manufacturer received the voluntary event report form (mw5058423) from the fda on 05-jan-2016.This complaint is related to mdr #1828100-2015-01017.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the system-1 was taken to the operating room for a procedure.After being unplugged and taken to the operating room and after approximately two to three minutes, the machine completely powered down.The machine has back-up batteries that did not keep the machine powered up while it was unplugged.The disposables were removed from that machine and set-up on another machine.The machine was then taken out of service and their biomedical department was called to communicate this incident with the manufacturer.The patient was not effected by this incident.No other details regarding the nature of this event were provided.

Manufacturer Narrative

Please reject the initial emdr #1828100-2016-00046 for this complaint.After further diligence and review this reported issue is considered a duplicate of emdr #1828100-2015-01017.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: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5398435
• MDR Text Key: 37621903
• Report Number: 1828100-2016-00046
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2011
• 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