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

Model Number 11160

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the customer the water cycles when they switch between hot and cold configuration.Part of the rubber on one of the relay switches is worn out.This heater cooler is no longer serviced by the manufacturer so no repairs will be made.The customer reports that the unit has been disposed of.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the rubber manifold of the switch was leaking.The user added more water to the unit and continued to use.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during a cpb case the perfusionist had a slow drip on the back of the heater cooler.They added more water to the unit and put a towel below the leak to mitigate any puddles of water on the floor that would cause a slip.The unit worked to cool and warm the patient efficiently during the case.The unit was not changed out until after the procedure, in which biomed noticed that the rubber manifold was leaking, therefore causing the external leak.There was no delay due to the incident with the dual heater cooler.The patient was warmed on bypass with the device, and there was no blood loss nor harm associated with the event.

• Brand Name: SARNS DUAL COOLER HEATER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6976545
• MDR Text Key: 91130668
• Report Number: 1828100-2017-00488
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• 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: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/1979
• 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