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

Model Number 11160

Device Problem Insufficient Heating (1287)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00533 (same user facility, different unit).This reported issue was not verifiable.The unit can not be serviced by the manufacturer and the customer cannot order replacement parts due end of service for the dual cooler heaters was 31-dec-2014.Manufacturer technical support (ts) informed the user facility¿s biomedical engineer (biomed) that the cooler heater was no longer supported and there are no parts.The biomed did not know when this occurred.The biomed asked what could replace this unit and ts informed him we sell the csz hemotherm.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the 4 pin connector had heated and melted on the printed circuit board assembly (pcba) of the cooler heater unit.This unit would not heat.No other details regarding the nature of this event were provided.

• Brand Name: SARNS DUAL COOLER HEATER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS- SARNS DUAL COOLER/HEATER SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5846779
• MDR Text Key: 51372679
• Report Number: 1828100-2016-00532
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• 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?: Yes
• Date Manufacturer Received: 07/14/2016
• 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