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Sigma Spectrum Infusion System with MDL (2014-02-10)
- Starting date:
- February 10, 2014
- Posting date:
- March 21, 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-38487
Recalled Products
Sigma Spectrum Infusion System with MDL
Reason
Baxter has received complaints for repeated system error 322 "link switch error (low)" occurrences with the Sigma Spectrum Infusion System. This error may occur when there is a miscommunication with the two internal switches that detect door closure. If system error 322 occurs during infusion, the Sigma Spectrum Infusion System stops infusing. An audible alarm and visual alarm will also occur.
Affected products
Sigma Spectrum Infusion System with MDL
Lot or serial number
- 35700
- 35700BAX
- 35700BAXT
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Baxter Healthcare Corp.
711 Park Ave.
Medina
14103
New York
UNITED STATES