System, Dialysate Delivery, Single Patient
FDA adverse event reports and recall history for system, dialysate delivery, single patient (product code FKP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,072
- Deaths
- 93
- Injuries
- 296
- Malfunctions
- 607
Reports per year
Source: FDA adverse event reports by year received, 2003–2021. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-08-15TerminatedComponent design/selection
Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 2010-08-15TerminatedComponent design/selection
Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 2010-04-12TerminatedSoftware change control
Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.
- 2008-09-21TerminatedNonconforming Material/Component
HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles containing 100 strips each, 5 bottles per kit, Part #811909. The firm name on the label is Hach, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.
Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
- 2008-09-21TerminatedNonconforming Material/Component
HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse water down to 0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per shipping case, Product #821972. The firm name on the label is HACH Company, Ames, IA. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.
Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
- 2008-09-21TerminatedNonconforming Material/Component
RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for Total Chlorine & Chloramines down to 0.1 ppm (mg/l), packaged in a 1/100-strip bottle, 60 bottles per tray, 5 trays per shipping case, Product code K100-0106 (HACH Part #812004). The label shows the product is Manufactured for Reprocessing Products Corp. (RPC), Minneapolis, MN. The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.
Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
- 2008-09-21TerminatedNonconforming Material/Component
HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bags containing 1/100-strip bottle, one medicine cup, and one insert. Each bag is sealed and labeled "812144 SteriChek Sensitive, Bagged, " 56 bags per cardboard tray, 5 trays per shipping case. Product code 812144 The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water used to prepare dialysate.
Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results
- 2006-04-18TerminatedOther
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
The older style 'Through Hardware' Dialysate Monitoring Manifolds and 'Noryl' Ultra Filtration Removal Regulators may become cracked due to mechanical and thermal stress. If either of these parts become cracked during patient treatment, there is the potential for an ultrafiltration error to occur, which can result in excessive removal of fluid from the patient.
- 2004-12-02TerminatedOther
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
The air detector may not detect air bubbles consistently at the selected limit.
- 2003-05-15TerminatedOther
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
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