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Medfusion 4000 (2013-11-25)
- Starting date:
- November 25, 2013
- Posting date:
- January 6, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37263
Recalled products
- Medfusion 4000
Reason
In May 2013, Smiths Medical received a complaint concerning a Medfusion 4000 pump with thermal damage to the AC receptacle as a result of an electrical short. An in-depth investigation performed by a third-party laboratory, concluded that an electrical short can occur when saline solution or other conductive fluids (ie. Potassium chloride) enter the pump's AC power receptacle. When this happens, sparking and/or flames, accompanied by smoke, may appear at the power receptacle. The pump and AC power cord are constructed of flame retardant materials, therefore, the sparks/flames extinguish within seconds.
Affected products
A. Medfusion 4000
Lot or serial number
More than 100 numbers, contact manufacturer.
Model or catalog number
- 4000-0100-50
- 4000-0101-50
- 4000-0101-51
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul
55112
Minnesota
UNITED STATES