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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL FRESENIUS DIAYSIS MACHINE

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FRESENIUS MEDICAL FRESENIUS DIAYSIS MACHINE Back to Search Results
Model Number 2008T
Device Problems Component Falling (1105); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2017
Event Type  malfunction  
Event Description
Dialysis 2008t machine fell over due to a caster breaking off its mounting. The machine was not being transported at the time of the incident. It was simply standing in a rinse cycle. The machine is only four years old. When examined, the caster is mounted directly into a threaded socket that is cast into the plastic chassis. These seems like an inherently weak design. Several of the supporting plastic mounts had fractures in them. The standard repair is to replace the entire chassis. This is very time consuming, but even more important someone standing next to the unit or a pt being treated could be harmed. Mfr was contacted, but offered no concern other than treating this as a normal failure and repair.
 
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Brand NameFRESENIUS
Type of DeviceDIAYSIS MACHINE
Manufacturer (Section D)
FRESENIUS MEDICAL
concord CA 94520
MDR Report Key6279317
MDR Text Key65941421
Report NumberMW5067478
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2008T
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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