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

Model Number 11160

Device Problem Low impedance (2285)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

After use of the device for a cardiopulmonary bypass procedure, the user facility's biomedical engineer (biomed) reported that the line isolation monitor (lim) alarm in the operating room (o/b) went off.The unit was removed from the operating room (o/r) and sent to biomed for repair.Another available unit was brought in to operating room.There was no pt involvement.

Manufacturer Narrative

Further testing by the biomed found that the power switch was broken on the cooler heater unit.The biomed will be making the repairs to the cooler heater unit at the user facility.

• 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: 4426831
• MDR Text Key: 5374048
• Report Number: 1828100-2014-01158
• 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: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• 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: 12/22/2014
• 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