Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.
Recall
- Recall Number
- Z-0605-03
- Event Number
- 25079
- Firm
- Baxter Healthcare Corp. Rt
- FEI Number
- 1416980
- Product Code
- KDI
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 15, 2002
- Posted
- March 5, 2003
- Terminated
- September 19, 2003
- Address
- 120 & Wilson Rd, Round Lake, IL, 60073
Description
Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.
Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.
Baxter issued a Safety Alert letter dated 11/15/02 to the direct accounts informing them of the potential for incomplete disinfection of the Meridian instrument during the Renalin/Formalin disinfection cycle due to electomagnetic interference (EMI). The accounts were informed that they will be receiving a radio frequency interference (RFI) filter kit and installation instructions to eliminate EMI by 2/28/03. The accounts were given instructions to follow to ensure that the Renalin/Formalin disinfection cycle has been completed prior to use of the machine.
Nationwide, Mexico, China, South Korea, Hong Kong
2864 units