System, Dialysate Delivery, Sealed
Gastroenterology, Urology · 21 CFR 876.5860
Recent MDR events
3,214 adverse event reports on file
- 2008 MACHINEApr 3, 2014Injury3792891
- REVEACLEAR DIALYIZERJan 10, 2014InjuryGambroMW5033856
- GAMBRO REVACLEAR DIALYZER K6Dec 13, 2013InjuryGambroMW5033463
- 2008K HEMODIALYSIS MACHINCENov 21, 2013MalfunctionFresenius Medical Care North AmericaMW5033115
- *May 15, 2013MalfunctionFresenius Usa, Inc3115213
- 5 LITER ACCESSORY DRAIN BAGDec 10, 2012MalfunctionGambro-renal Products2886107
- FRESENIUS DIALYSIS DELIVERY SYSTEMApr 26, 2012DeathFresenius Medical Care North America2937457-2012-00017
- GAMBROJan 11, 2012DeathGambro2417674
- CRRT MACHINEDec 20, 2010MalfunctionGambro Renal Products, Inc.1941545
- GAMBRONov 29, 2010MalfunctionGambro Americas HeadquartersMW5018406
Event type breakdown
Recalls
2 recall events for this product code
- Baxter Healthcare Renal DivTerminatedDec 24, 2004
System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 6
Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism.
Z-0367-05 · View FDA record ↗ - Baxter Healthcare Renal DivTerminatedJul 20, 2004
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina
These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.
Z-0583-04 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
5 clearances for this product code
- Nxstage Medical, Inc.Jul 7, 2003
K030470 · NXSTAGE SYSTEM ONE
- Gambro, Inc.Aug 24, 1988
K881270 · GAMBRO MULTIPURPOSE SYSTEM MPS-10
- Travenol Laboratories, S.A.Oct 13, 1987
K872364 · HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
- Gambro, Inc.Sep 9, 1986
K862716 · HEMOFILTRATION SYSTEM 10
- Hospal Medical Corp.Oct 6, 1982
K822386 · COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA