MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (HEART LUNG CONSOLE)

Model Number 801074

Device Problems Loose or Intermittent Connection (1371); Out-Of-Box Failure (2311); Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

Upon receipt of the device, the user reported that the oxygen (o2) sensor would not energize and unit would not calibrate.This is considered an "out of box" failure.There was no pt involvement.

Manufacturer Narrative

The user facility's biomed spoke with technical support (ts) regarding the reported issue.Ts was able to resolve the biomed's issue, as the gas lines were not securely connected, therefore the sensor is likely fine.The oxygen sensor is currently installed in the system with no further issues reported.If add'l info 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: APS 1 (HEART LUNG CONSOLE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4730257
• MDR Text Key: 19640320
• Report Number: 1828100-2015-00305
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/31/2015

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 Expiration Date: 03/31/2015
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Device Lot Number: 12386-110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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