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 811104

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During laboratory evaluation, the flowmeter met specification for flow accuracy during lab testing.The product surveillance technician (pst) installed the flowmeter into a lab-use only (luo) epgs.He calibrated the epgs, set the o2 % at 100 and tested the flowmeter at 1, 5 and 9 liters per minute (l/min).The flowmeter met specification as shown below: set point = 1 l/min ccm = 0.99 l/min external flowmeter = 0.99 l/min specifications = 0.9-1.1 l/min.Set point = 5 l/min ccm = 4.99 l/min external flowmeter = 5.04 l/min specifications = 4.8-5.2 l/min.Set point = 9 l/min ccm = 8.99 l/min external flowmeter = 9.12 l/min specifications = 8.7-9.3 l/min.The pst observed nothing that would cause failure.

Event Description

Upon receipt of the device (during electronic patient gas system [epgs] phase 2 testing), the service repair technician (srt) reported that the gas flowmeter failed flowmeter accuracy testing.This is considered an "out of box failure".There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.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: 5537757
• MDR Text Key: 41550368
• Report Number: 1828100-2016-00218
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• 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: 08/12/2016

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: Other
• Device Model Number: 811104
• Device Catalogue Number: 811104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 03/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• 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