MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO POWDER CONCENTRATES AND MIXER; KPO

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problems Respiratory Distress (2045); No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2015

Event Type  malfunction  

Event Description

Fresenius medical care north america marketing was notified by our customer, fresenius medical services (fms), on (b)(4) 2015 of an issue pertaining to the neutralization process as outlined in the operators manuals for fresenius dissolution units.Fms was concerned about the generation of co2 while following the neutralization process as described in the fresenius dissolution units operators manuals.As a result, our customer fms contacted a 3rd party consulting firm specializing in industrial hygiene to monitor co2 levels when performing the neutralization process at one of their facilities.Co2 monitoring during the process created an excess of co2 that peaked above the idlh of 4% of 40000ppm.

Manufacturer Narrative

An investigation is currently underway and f/u will be submitted at the conclusion of the investigation and upon receipt of additional info.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The serial number for the machine was not provided therefore the device history review could not be performed.This event is being investigated via a capa.

• Brand Name: GRANUFLO POWDER CONCENTRATES AND MIXER
• Type of Device: KPO
• 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 02451-1457 ; 7816999000
• MDR Report Key: 4478030
• MDR Text Key: 5327002
• Report Number: 2937457-2015-00113
• 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: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other