MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS DUAL COOLER/HEATER SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS DUAL COOLER/HEATER SYSTEM

Model Number 11160

Device Problems Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.The fsr confirmed the noise as being one of the solenoid valves which needed cleaning.The valve was cleaned and was no longer noisy.The unit operated to manufacturer specifications and was returned to clinical use.A mdr remediation activity related to manufactured devices with a fda product code dwc: controller, temperature, cardiopulmonary bypass heater cooler" was conducted.This report is a result of the "heater" cooler response remediation protocol 02-jun-2016.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, he discovered a noise from the cooler heater unit when set in cooling mode.There was no patient involvement.

• Brand Name: SARNS DUAL COOLER/HEATER SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS DUAL COOLER/HEATER SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5720531
• MDR Text Key: 48159471
• Report Number: 1828100-2016-00427
• 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: Other
• Type of Report: Initial
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• 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: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2004
• 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