MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS TCM HEATING AND COOLING SYSTEM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM HEATING AND COOLING

Model Number 4415

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the perfusionist (ccp): the user facility has been pretty strict on the prescribed maintenance schedule per the manual.The user facility has a larger issue with an ongoing battle with water quality.The user does not measure how much chlorine they use for cleaning.They were taught if they can smell it, then they are good.The reported complaint was confirmed.The field service representative (fsr) verified debris in hansen fittings and the difficulty in operating.The fsr drained the unit, removed the main, cardioplegia and blanket fittings from unit.He flushed the unit with connectors removed and installed new fittings.The remaining parts were given to the customer so they may construct new external lines as a precautionary measure.Preventative maintenance (pm) was completed and the unit operated to manufacturer specifications and was returned to service.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

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the customer mentioned that they have been having issues with the hansen fittings on the cooler heater unit.Even with their stringent cleaning program there is still debris in fittings and are hard to operate.This has been an ongoing issue.The unit still functions.The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

• Brand Name: SARNS TCM HEATING AND COOLING SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM HEATING AND COOLING
• 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: 5720839
• MDR Text Key: 48158623
• Report Number: 1828100-2016-00433
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2010
• 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