Definition: For Processing Hematopoietic Progenitor Cells-apheresis (HPC-A) From An HLA-identical Donor To Obtain A CD34 Positive Cell Enriched Population That Will Provide For Hematopoietic Reconstitution Following A Myeloablative Preparative Regimen Without Th
| Device Type ID | 2503 |
| Device Name | Magnetic Cell Selection System For Cd34+ Cells From Hpc-apheresis Used In Treatment Of Acute Myeloid Leukemia (aml) |
| Physical State | Anti-CD34 Antibody, Paramagnetic Dextran Beads, Tubing, Permanent Magnet, Software Controlled Pumps And Valves, Buffers, Filters, Polymer Bags |
| Technical Method | To Select CD34+ Hematopoietic Progenitor Cells From Apheresis (HPC-A) Labeled With Antibody Conjugated To Paramagnetic Beads Using A Semiautomated Magnetic Column. |
| Target Area | Hematopoietic Progenitor Cells-apheresis (HPC-A) Separated From Whole Blood. |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | OVG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2503 |
| Device | Magnetic Cell Selection System For Cd34+ Cells From Hpc-apheresis Used In Treatment Of Acute Myeloid Leukemia (aml) |
| Product Code | OVG |
| Device Problems | |
|---|---|
Device Issue | 32 |
Device Operates Differently Than Expected | 13 |
Fluid Leak | 8 |
Insufficient Information | 4 |
Failure To Pump | 4 |
Appropriate Term/Code Not Available | 3 |
Missing Value Reason | 3 |
Device Maintenance Issue | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Device Difficult To Maintain | 1 |
Connection Problem | 1 |
Disassembly | 1 |
Particulates | 1 |
Device Stops Intermittently | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Complete Blockage | 1 |
Mechanical Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Loose Or Intermittent Connection | 1 |
Material Rupture | 1 |
| Total Device Problems | 84 |