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

Model Number 801763

Device Problem Failure to Run on Battery (1466)

Patient Problem Not Applicable (3189)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the system-1 did not boot up on battery and after charging several hours, it failed on battery power when the plug was removed from the wall.This is a spare and has been in storage since the last pm in (b)(6).Since the event occurred during preventative maintenance, there was no patient involvement.

Manufacturer Narrative

When the field service representative (fsr) went back to replace the batteries, he found that the original batteries had charged successful overnight.The fsr replaced batteries and the unit operated to manufacturer specifications and was returned to clinical use.The fsr is sending in the system and power manager data logs for further evaluation.The suspect batteries was returned to the manufacturer for further evaluation.The reported issue was no duplicated during laboratory evaluation.Both batteries were received in a near-full charged condition with passing conductance values.Both batteries passed load testing minimum requirements.

• 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: 3979780
• MDR Text Key: 4884207
• Report Number: 1828100-2014-00546
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 06/10/2014

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: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2005
• 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