2024-20999. Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System

Table 1—Pediatric Continuous Renal Replacement Therapy System Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Adverse tissue reaction	Biocompatibility evaluation, Pyrogenicity testing, and Non-clinical performance testing.
Death	Labeling, Clinical performance testing, and Usability testing.
Infection	Labeling, Reprocessing validation, Pyrogenicity testing, Shelf life testing, and Usability testing.
Inadequate or incomplete treatment	Non-clinical performance testing; Clinical performance testing; Labeling; Shelf-life testing; Usability testing; and Software verification, validation, and hazard analysis.
Clearance of essential blood substances or medications	Non-clinical performance testing; Clinical performance testing; Labeling; Shelf-life testing; Usability testing; and Software verification, validation, and hazard analysis.
Blood loss or blood cell destruction	Non-clinical performance testing; Clinical performance testing; Labeling; Shelf-life testing; and Software verification, validation, and hazard analysis.
Thermal injury	Non-clinical performance testing; Clinical performance testing; Labeling; Shelf-life testing; Usability testing; and Software verification, validation, and hazard analysis.
Blood leak into the dialysis fluid	Non-clinical performance testing; Clinical performance testing; Labeling; Shelf-life testing; and Software verification, validation, and hazard analysis.
Fluid imbalance	Non-clinical performance testing; Clinical performance testing; Labeling; Shelf-life testing; and Software verification, validation, and hazard analysis.
Air embolism	Non-clinical performance testing; Clinical performance testing; Labeling; Shelf-life testing; Usability testing; and Software verification, validation, and hazard analysis.
Fluid pump(s) reversal resulting in air infusion via the arterial bloodline	Non-clinical performance testing; Clinical performance testing; Labeling; Shelf-life testing; Usability testing; and Software, verification, validation, and hazard analysis.
Electrical shock	Electrical safety testing.
Electromagnetic interference with other devices/equipment	Electromagnetic compatibility (EMC) testing.