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

Model Number 801763

Device Problems Failure to Charge (1085); Failure to Run on Battery (1466)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity, the perfusion system was being rolled into an operating room with the power on and the system lost power.There was no pt involvement.

Manufacturer Narrative

Eval is in progress, but not yet concluded.The field service rep (fsr) verified that the system does not hold a charge.The fsr turned the system on and left it to charge overnight.The fsr returned and the batteries were fully charged and the power manager was still in charge mode.He unplugged the system and the batteries drained quickly.The fsr replaced the batteries adn power manager printed circuit board (pcb).The fsr charged the batteries adn checked the system.The unit operated to manufacturer specs and was returned to clinical use.The suspect parts were returned to the manufacturer for further eval.

• 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: 4620412
• MDR Text Key: 5652913
• Report Number: 1828100-2015-00206
• 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: 02/24/2015

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 Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2009
• 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