MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. DUAL COOLER/HEATER; COLLING AND HEATING SYSTEM

Model Number 11160

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

The field service representative (fsr) reported that during preventative maintenance (pm) of the device, the cooler heater unit leaks in several areas inside compartment (leaking at elbow pvc joint be water outlet and leaking at tubing underneath 0-50 thermostat).Since the event occurred during preventative maintenance, there was no pt involvement.

Manufacturer Narrative

The field service representative (fsr) notified the user facility's biomedical engineer (biomed) that he will return at a later date with parts that may be required to perform repairs.

• Brand Name: DUAL COOLER/HEATER
• Type of Device: COLLING AND HEATING SYSTEM
• 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: 3726844
• MDR Text Key: 4330188
• Report Number: 1828100-2013-01162
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• 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: 12/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11160
• Device Catalogue Number: 11160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2006
• 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