QIRClass IILife-sustaining
Pediatric Hemodialysis System
Gastroenterology, Urology · 21 CFR 876.5861
For use in acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy. It is intended to provide continuous renal replacement therapy (CRRT) to patients weighing between 2.5 and 10 kilograms.
MDR events37All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances1All time
Recent MDR events
37 adverse event reports on file
- UNKNOWN RENAL CARE PRODUCTNov 3, 2025InjuryBellco Srl1000312731-2025-00020
- CARPEDIEMSep 5, 2025MalfunctionBellco Srl1000312731-2025-00019
- CARPEDIEMAug 25, 2025MalfunctionBellco Srl1000312731-2025-00018
- CARPEDIEMAug 25, 2025MalfunctionBellco Srl1000312731-2025-00016
- CARPEDIEMAug 25, 2025MalfunctionBellco Srl1000312731-2025-00017
- CARPEDIEMAug 25, 2025MalfunctionBellco Srl1000312731-2025-00015
- CARPEDIEMAug 18, 2025MalfunctionBellco Srl1000312731-2025-00014
- CARPEDIEMAug 11, 2025MalfunctionBellco Srl1000312731-2025-00013
- CARPEDIEMJun 25, 2025MalfunctionBellco Srl1000312731-2025-00010
- CARPEDIEMJun 25, 2025MalfunctionBellco Srl1000312731-2025-00009
Event type breakdown
Malfunction25
Injury9
Death3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
1 clearances for this product code