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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device magnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml)
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 the need for additional graft-vs-host disease (GVHD) prophylaxis.
Product CodeOVG
Device Class Humanitarian Device Exemption

Device Problems
Device Issue 32
Device operates differently than expected 12
Fluid leak 8
No Information 4
No code available 3
Failure to pump 3
Device maintenance issue 3
No Known Device Problem 2
Device Difficult to maintain 1
Foreign material present in device 1
Mechanical issue 1
Particulates 1
Connection issue 1
Detachment of device or device component 1
Material rupture 1
Device stops intermittently 1
Improper or incorrect procedure or method 1
Loose or intermittent connection 1
Device clogged 1
Disassembly 1
Total Device Problems 79