MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO MIXER; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) MIXER

Catalog Number RTLG047-80101

Device Problems Fire (1245); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Event Description

A user facility reported that a mixer motor that had began to smoke upon power up and was immediately shut down.The unit then stopped working.A biomedical technician replaced the damaged motor with a new motor and assembly shaft.The old motor and assembly are not available for investigation as the parts were discarded.The unit is now operational.There was no harm or adverse event reported for patients or facility staff and no treatment was impacted.

Manufacturer Narrative

The actual device was not evaluated by fresenius personnel; therefore, the failure mode cannot be confirmed or replicated in field testing.However, the facility reported that the issue was resolved by replacing the granmixer motor.The issue has not occurred again and the machine is operational.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformities during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material and process controls were within specification.

• Brand Name: GRANUFLO MIXER
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) MIXER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord plant; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5374586
• MDR Text Key: 36393320
• Report Number: 2937457-2016-00053
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: RTLG047-80101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2009
• 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