TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, hemodialysis, triple lumen, non-implanted
Definition	Short-term (< 30 days) central venous access for hemodialysis and apheresis, with a third lumen for infusion.
Product Code	NIE
Regulation Number	876.5540
Device Class	2

Premarket Reviews
Manufacturer	Decision
HEALTH LINE INTERNATIONAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL COMPONENTS INC. (DBA MEDCOMP)
	SUBSTANTIALLY EQUIVALENT - KIT	1
	SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	85	85
Material Deformation	54	54
Obstruction of Flow	42	42
Material Frayed	41	41
Adverse Event Without Identified Device or Use Problem	41	41
Break	30	30
Material Puncture/Hole	25	25
Defective Component	24	24
Detachment of Device or Device Component	20	20
Difficult to Remove	18	18
Device Dislodged or Dislocated	16	16
Material Twisted/Bent	12	12
Component Incompatible	10	10
Failure to Infuse	10	10
Product Quality Problem	10	10
Unraveled Material	8	8
Material Fragmentation	8	8
Leak/Splash	7	7
Contamination /Decontamination Problem	7	7
Physical Resistance/Sticking	6	6
Insufficient Information	6	6
Nonstandard Device	5	5
Insufficient Flow or Under Infusion	5	5
Gas/Air Leak	5	5
Material Integrity Problem	5	5
Suction Problem	4	4
Difficult to Advance	4	4
Difficult to Insert	4	4
Failure to Advance	3	3
Infusion or Flow Problem	3	3
Material Too Rigid or Stiff	3	3
Collapse	3	3
Migration or Expulsion of Device	3	3
Material Split, Cut or Torn	3	3
Disconnection	3	3
Device Markings/Labelling Problem	2	2
Malposition of Device	2	2
Deformation Due to Compressive Stress	2	2
Deflation Problem	1	1
Backflow	1	1
Device Difficult to Setup or Prepare	1	1
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Structural Problem	1	1
Crack	1	1
Misassembled	1	1
Material Rupture	1	1
Device Alarm System	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	236	236
Insufficient Information	59	59
No Consequences Or Impact To Patient	58	58
Swelling/ Edema	48	48
Erythema	47	47
No Known Impact Or Consequence To Patient	30	30
Foreign Body In Patient	15	15
Hemorrhage/Bleeding	14	14
Death	7	7
Hematoma	6	6
Unintended Radiation Exposure	5	5
No Patient Involvement	4	4
Blood Loss	3	3
No Information	2	2
Exsanguination	2	2
Cardiac Arrest	2	2
Laceration(s)	2	2
Perforation of Vessels	2	2
Great Vessel Perforation	2	2
Abdominal Pain	1	1
Encephalopathy	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Arrhythmia	1	1
Fatigue	1	1
Radiation Exposure, Unintended	1	1
Skin Inflammation/ Irritation	1	1
Obstruction/Occlusion	1	1
Cardiac Tamponade	1	1
Injury	1	1
Cardiac Perforation	1	1
Renal Impairment	1	1
Hypoxia	1	1
Loss of consciousness	1	1
Hemothorax	1	1
Thrombus	1	1
Device Embedded In Tissue or Plaque	1	1
Aspiration Pneumonitis	1	1