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

Model Number 11160

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, there was no power to the pump on the cooler heater unit.The power light was illuminated.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the pt.

Manufacturer Narrative

The user facility's biomedical engineer (biomed) has not made the repairs to the cooler heater pump at this time.

• 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: 4110219
• MDR Text Key: 17291546
• Report Number: 1828100-2014-00760
• 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: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• 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: 08/19/2014
• 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