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

Model Number 11160

Device Problems Insufficient Heating (1287); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a procedure, the overheat light on the cooler heater unit came on and the unit would shut off.The unit only got up to 27 degrees.It would sit for a while then turn back on, but then shut off again.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

This is vet/science organization.Per technical support, the overtemp thermostat is bad.The customer is not going to have the manufacturer fix the cooler heater unit.The customer is not trained on this unit and can not order the part.The customer has no maintenance process and does not perform preventative maintenance (pm) on this unit, nor do they use chlorine to clean the unit.The customer does not use the unit very often and was not aware that it needed any type of pm.If additional info becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• 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: 4340558
• MDR Text Key: 5203924
• Report Number: 1828100-2014-01050
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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