TPLC - Total Product Life Cycle

• Device: system, photopheresis, extracorporeal
• Product Code: LNR
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
2	1	2	3	3	0

MDR Year	MDR Reports	MDR Events
2019	161	161
2020	141	141
2021	114	114
2022	97	97
2023	83	83
2024	25	25

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	323	323
Leak/Splash	157	157
Break	140	140
Adverse Event Without Identified Device or Use Problem	57	57
Device Displays Incorrect Message	21	21
Coagulation in Device or Device Ingredient	18	18
Protective Measures Problem	16	16
Crack	12	12
Use of Device Problem	10	10
Gas/Air Leak	9	9
Detachment of Device or Device Component	9	9
Output Problem	9	9
Display or Visual Feedback Problem	7	7
Material Puncture/Hole	6	6
Device Alarm System	6	6
Obstruction of Flow	5	5
Improper or Incorrect Procedure or Method	4	4
Noise, Audible	4	4
Air/Gas in Device	4	4
Disconnection	3	3
Unintended Ejection	3	3
Material Twisted/Bent	2	2
Explosion	2	2
Material Split, Cut or Torn	2	2
Pressure Problem	2	2
Problem with Software Installation	2	2
Therapeutic or Diagnostic Output Failure	1	1
Misassembly by Users	1	1
Insufficient Information	1	1
Device Fell	1	1
Priming Problem	1	1
Infusion or Flow Problem	1	1
Installation-Related Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Difficult to Open or Close	1	1
Device Dislodged or Dislocated	1	1
Failure to Auto Stop	1	1
Failure to Shut Off	1	1
Malposition of Device	1	1
Communication or Transmission Problem	1	1
Connection Problem	1	1
Material Frayed	1	1
Material Rupture	1	1
Material Separation	1	1
Unexpected Therapeutic Results	1	1
Use of Incorrect Control/Treatment Settings	1	1
Defective Alarm	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	314	314
No Known Impact Or Consequence To Patient	188	188
Dyspnea	21	21
Pulmonary Embolism	20	20
Blood Loss	16	16
No Code Available	14	14
Low Blood Pressure/ Hypotension	13	13
Tachycardia	12	12
Insufficient Information	11	11
No Consequences Or Impact To Patient	10	10
Thrombosis	9	9
Chest Pain	9	9
Anemia	8	8
Low Oxygen Saturation	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Nausea	6	6
Hemorrhage/Bleeding	5	5
Hypoxia	5	5
Pain	4	4
Dizziness	4	4
Malaise	4	4
Thrombus	4	4
Weakness	4	4
Tingling	3	3
Discomfort	3	3
Pallor	3	3
Fatigue	3	3
Paresthesia	3	3
Syncope/Fainting	2	2
Cough	2	2
Wheezing	2	2
Stroke/CVA	2	2
Fainting	2	2
Abdominal Pain	2	2
Air Embolism	2	2
Pulmonary Edema	2	2
Itching Sensation	2	2
Hematuria	2	2
Ambulation Difficulties	2	2
No Patient Involvement	2	2
No Information	2	2
Numbness	2	2
Neck Pain	2	2
Sweating	2	2
Chest Tightness/Pressure	2	2
Anxiety	2	2
Hemolysis	2	2
Swelling	2	2
Blurred Vision	2	2
Visual Impairment	1	1
Vomiting	1	1
Virus	1	1
Distress	1	1
Hypoxia in Utero	1	1
Urticaria	1	1
Chills	1	1
Burning Sensation	1	1
Respiratory Failure	1	1
Abdominal Cramps	1	1
Confusion/ Disorientation	1	1
Muscle Weakness	1	1
Myocardial Infarction	1	1
Unspecified Infection	1	1
Hypersensitivity/Allergic reaction	1	1
Hypovolemic Shock	1	1
Rash	1	1
Respiratory Distress	1	1
Sepsis	1	1
Septic Shock	1	1
Shock	1	1
Skin Discoloration	1	1
Paralysis	1	1
Pneumonia	1	1
Cyanosis	1	1
Diarrhea	1	1
Arrhythmia	1	1
Bacterial Infection	1	1
Bradycardia	1	1
Headache	1	1
Hematoma	1	1
Edema	1	1
Embolism	1	1
Facial Nerve Paralysis	1	1
Unspecified Hepatic or Biliary Problem	1	1
Muscle Hypotonia	1	1
Skin Inflammation/ Irritation	1	1
Swelling/ Edema	1	1
Movement Disorder	1	1
Ischemia Stroke	1	1
Multiple Organ Failure	1	1
Convulsion/Seizure	1	1
Embolism/Embolus	1	1
Thrombosis/Thrombus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mallinckrodt Pharmaceuticals Ireland Ltd	II	Feb-07-2022
2	Therakos, Inc.	II	Nov-05-2021