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

Model Number 802114

Device Problem Failure to Sense (1559)

Patient Problem Not Applicable (3189)

Event Date 05/21/2014

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the temperature module was not responding and the red light emitting diode (led) was flashing.Since the event occurred during preventative maintenance, there was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.During the inspection, the module would not show up in the inventory section on the central control monitor (ccm).The field service representative (fsr) downloaded the data logs for the entire system-1; however, he was not able to download the affected temperature module.The fsr removed the module and sent it to the manufacturer for further evaluation.The fsr did not install a new module as the customer does not use it.Per the customer's request, the module will not be replaced.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS (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: 3915765
• MDR Text Key: 16087453
• Report Number: 1828100-2014-00481
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 802114
• Device Catalogue Number: 802114
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2008
• 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