MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO MIXER

Catalog Number RTLG047-80101

Device Problems 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

The parts were not returned to the manufacturer for physical evaluation, and the plant investigation is on-going.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility reported an event of smoke emission from a granuflo mixer.During recirculation mode, mix motor turns on, propeller starts to turn, then smoke comes out of mix motor and machine powers down.There were no reported spark, flames, or any other visual abnormalities, besides smoke.No patient therapy was adversely affected.Smoke was seen emitting from the mixer motor when the mixer engaged for rinse.Immediately thereafter, the machine powered down.The biomedical technician was able to replace the mixer motor, and no further action was needed.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, the facility reported that they replaced the mixer pump which resolved the issue.The machine was returned to service with no further issue.No parts were returned for evaluation.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device history record review confirmed the labeling, material and process controls were within specification.

• Brand Name: GRANUFLO MIXER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 5313344
• MDR Text Key: 34131485
• Report Number: 2937457-2015-01719
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RTLG047-80101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2007
• 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