MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS, CORP. SARNS TCM 1 HEATING AND COOLING SYSTEMS; CONTROLLER, TEMPERATURE, CARDIOVACULAR BYPASS-SARNS TCM 1 HEATING AND COOLING

Model Number 15747

Device Problems Calcified (1077); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported complaint is confirmed.The srt indicated that the blanket loop hanson fitting output has been removed and cleaned three different times to remove calcium stone blockage, but the light still came on.A defective flow switch was changed to correct the blanket light issue.New hanson fittings were also installed at this time as a precaution.The unit operated to manufacturer specifications and was returned to clinical use.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 service repair technician (srt) reported that during routine testing of the cooler heater unit at the service center, the low flow to the blanket light comes on.There was no patient involvement.

• Brand Name: SARNS TCM 1 HEATING AND COOLING SYSTEMS
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOVACULAR BYPASS-SARNS TCM 1 HEATING AND COOLING
• 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: 5719905
• MDR Text Key: 47210254
• Report Number: 1828100-2016-00416
• 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: 15747
• Device Catalogue Number: 15747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2013
• 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