System, Dialysate Delivery, Semi-automatic, Peritoneal
Gastroenterology, Urology · 21 CFR 876.5630
Recent MDR events
161 adverse event reports on file
- LOW CA 1.5 PERCENT 2L/2L UB DIANEALJan 22, 2018InjuryBaxterMW5074708
- BAXTER PERITONEAL DIALYSIS DIANEALNov 30, 2015MalfunctionBaxter Healthcare Corp.5313841
- ASSY, CNTRL UNIT, FREEDOM CYCLER (REFURB)Jul 24, 2014InjuryFresenius Medical Care North America2937457-2014-01840
- FREEDOM CYCLER, FREEDOM 5-LEAD PEDIATRIC CYCLER SETJul 24, 2014InjuryFresenius Medical Care North America8030665-2014-00575
- ASSY, CNTRL UNIT, FREEDOM CYCLER (REFURB)Jul 24, 2014InjuryFresenius Medical Care North America2937457-2014-01839
- ASSY, CBTRK YBUTM FREEDOM CYCLER (REFURB)Jul 24, 2014InjuryFresenius Medical Care North America2937457-2014-01838
- FREEDOM CYCLER SET, 5 LEAD 5-L PEDIATRIC CYCLERJul 24, 2014InjuryFresenius Medical Care North America8030665-2014-00574
- LIBERTY CYCLERDec 5, 2011InjuryFreseniusMW5023362
- LIBERTY CYCLERDec 5, 2011InjuryFreseniusMW5023363
- FREEDOM CYCLER PD+Jan 11, 2007MalfunctionFresenius Medical Care-north America2937457-2007-00001
Event type breakdown
Recalls
5 recall events for this product code
- Baxter Healthcare Renal DivTerminatedJan 26, 2008
Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60
Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).
Z-0527-2008 · View FDA record ↗ - Baxter Healthcare Renal DivTerminatedJan 26, 2008
Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with "No Heparin" orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).
Z-0528-2008 · View FDA record ↗ - Baxter Healthcare Renal DivTerminatedMay 3, 2006
Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter H
Software Error: There are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
Z-0831-06 · View FDA record ↗ - Baxter Healthcare Renal DivTerminatedMay 3, 2006
Baxter Healthcare Corporation, RenalSoft v.1.1 - PD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085
Software Error: There are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
Z-0832-06 · View FDA record ↗ - Baxter Healthcare Renal DivTerminatedMay 3, 2006
Baxter Healthcare Corporation, Renal Software Suite v.3.1 - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60
Software Error: There are software discrepancies that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.
Z-0833-06 · View FDA record ↗
Registered firms
2 firms currently registered for this product code
510(k) clearances
13 clearances for this product code
- Baxter Healthcare CorpSep 11, 2006
K061515 · RENALSOFT
- Baxter Healthcare CorpJun 18, 1999
K990953 · RENAL LINK
- Cybernius Medical , Ltd.Jul 24, 1997
K970989 · CYBERREN
- Fresenius USA, Inc.Jul 31, 1996
K955762 · PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
- DencoMay 26, 1994
K913515 · TOTAL CONTAINMENT DEVICE
- Amicon, Inc.Feb 19, 1988
K875121 · AMICON EQUALINE FLUID BALANCE SYSTEM
- Abbott LaboratoriesJan 29, 1988
K874020 · ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
- Medionics International , Ltd.Jul 28, 1982
K821328 · C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP