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

Model Number 4415

Device Problems Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2012

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to medwatch #1828100-2012-01224.The reported complaint was confirmed.Inspection of the pump by the fsr found that the impeller and housing were badly worn.It was also noted that a huge chunk of mineral deposit was wedged in the impeller housing area.The fsr replaced the impeller magnet, spindle and housing.After parts replacement, a pm inspection was performed and the cooler heater unit operated to manufacturer specifications and was returned to clinical use.The parts were returned to the manufacturer.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

The field service representative (fsr) reported that during preventive maintenance (pm) of the cooler heater unit, the impeller motor was noisy.There was no patient involvement.

• Brand Name: SARNS TCM II HEATING AND COOLING SYSTEM
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II 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: 5720475
• MDR Text Key: 48154950
• Report Number: 1828100-2016-00426
• 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
• 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

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4415
• Device Catalogue Number: 4415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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