MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. DUAL COOLER/HEATER; SARNS DUAL COOLER/HEATER

Model Number 11160

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

The biomedical engineer (biomed) reported that during preventative maintenance (pm) of the device, the cooler heater unit was leaking water on the floor.This issue was found by a third party biomedical engineer (biomed) group, the week of (b)(6) 2014.Since the event occurred during preventative maintenance, there was no patient involvement.

Manufacturer Narrative

(b)(4) hired a third part group to perform the pm.The biomed determined the issue to the cold valve and will be repairing the cooler heater unit at the hospital.

• Brand Name: DUAL COOLER/HEATER
• Type of Device: SARNS DUAL COOLER/HEATER
• 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: 3995305
• MDR Text Key: 4778987
• Report Number: 1828100-2014-00504
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11160
• Device Catalogue Number: 11160
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: No
• 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