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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA: WALNUT CREEK PLANT FRESENIUS 2008K@HOME
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FRESENIUS MEDICAL CARE NORTH AMERICA: WALNUT CREEK PLANT FRESENIUS 2008K@HOME Back to Search Results
Model Number K@HOME
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 01/09/2012
Event Type  malfunction  
Event Description
It was reported by a patient/user of the fmc hemodialysis device, the venous pressure pump runs continuously while the venous clamp is open.Customer advised to replace level detector module.
 
Manufacturer Narrative
This event was managed by a fmc regional equipment specialist (res).It was determined the level detector module required replacement.The device was not operational until the detector module was replaced and calibrated by the customer function checks completed by customer.Machine released for service.Upgraded (b)(4).A device history record was extracted and device met requirements.This is a retrospective mdr being submitted by fresenius medical care as a remedication action committed to fda regarding all potential adverse events received between (b)(6) 2011 to (b)(6) 2013.
 
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Brand Name
FRESENIUS 2008K@HOME
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA: WALNUT CREEK PLANT
Manufacturer (Section G)
CONCORD
4040 nelson ave.
concord CA 94520
Manufacturer Contact
tanya taft, rn, cnor
920 winter street
waltham, MA 02451-1457
7816999000
MDR Report Key4084811
MDR Text Key4825810
Report Number2937457-2014-02200
Device Sequence Number1
Product Code ONW
Combination Product (y/n)N
PMA/PMN Number
K070049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Type of Report Initial
Report Date 01/12/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberK@HOME
Device Catalogue Number190395
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/12/2012
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 Number1
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