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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


Premarket Reviews
ManufacturerDecision
MILTENYI BIOTEC, INC.
  APPROVED 14
  30 DAY - NO 75 DAY SUPPLEMENT NEEDED 18

MDR Year MDR Reports MDR Events
2015 23 23
2016 54 54
2017 10 10
2018 1 1
2019 2 2
2020 2 2
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Issue 32 32
Device Operates Differently Than Expected 13 13
Fluid/Blood Leak 10 10
Adverse Event Without Identified Device or Use Problem 7 7
Appropriate Term/Code Not Available 7 7
Insufficient Information 6 6
Failure to Pump 4 4
Missing Value Reason 3 3
Device Maintenance Issue 3 3
Mechanical Problem 1 1
Particulates 1 1
Device Contamination with Chemical or Other Material 1 1
Naturally Worn 1 1
Device Difficult to Maintain 1 1
Material Rupture 1 1
Device Stops Intermittently 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Complete Blockage 1 1
Disassembly 1 1
No Display/Image 1 1
Overfill 1 1
Incorrect Or Inadequate Test Results 1 1
Device Displays Incorrect Message 1 1
Patient-Device Incompatibility 1 1
Computer Operating System Problem 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 62 62
No Known Impact Or Consequence To Patient 34 34
Death 5 5
Pericardial Effusion 2 2
Insufficient Information 2 2
Bacterial Infection 2 2
Foreign Body Reaction 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Respiratory Distress 2 2
Septic Shock 1 1
Ventricular Tachycardia 1 1
Weakness 1 1
No Consequences Or Impact To Patient 1 1
Complaint, Ill-Defined 1 1
Loss of consciousness 1 1
Chest Tightness/Pressure 1 1
Respiratory Failure 1 1
Confusion/ Disorientation 1 1
Weight Changes 1 1
Pleural Effusion 1 1
Pulmonary Insufficiency 1 1
Rash 1 1
Renal Failure 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Abdominal Pain 1 1
Atrial Fibrillation 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Multiple Organ Failure 1 1
Lymphoma 1 1
Diarrhea 1 1
Dyspnea 1 1
Test Result 1 1

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