MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K

Model Number 16404

Device Problem Device Inoperable (1663)

Patient Problem Not Applicable (3189)

Event Date 05/27/2014

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity (in customer's biomed lab), the customer has never used the safety monitor's level detector since they bought the system.They have relied on the capiox low-level alarm.As parts and service are no longer available for the capiox unit, the customer requested their distributor to help set-up the perfusion system's level detector.When the distributor showed up, they were informed it was not working and that it could be the cable or the board itself.There was no patient involvement.

Manufacturer Narrative

Per technical support, the customer swapped a board from another 8k system and determined the problem was caused by a bad circuit board.When the customer called to order a replacement part, they were informed by the manufacturer's customer service they had to order it through their distributor.The customer disposed of the suspect part, therefore, no part will be returned to the manufacturer for further evaluation.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K
• 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: 3995296
• MDR Text Key: 4778989
• Report Number: 1828100-2014-00540
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915183
• 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: 05/27/2014

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: Health Professional
• Device Model Number: 16404
• Device Catalogue Number: 16404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2014
• Initial Date FDA Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2004
• 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
• Treatment: CAPIOX LOW-LEVEL ALARM