TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ELCAM MEDICAL ACAL
	SUBSTANTIALLY EQUIVALENT	1
M/S ROMSONS INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	1
YOMURA TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	967	967
Leak/Splash	382	382
Disconnection	236	236
No Flow	178	178
Crack	167	167
Break	125	125
Device Contamination with Chemical or Other Material	117	117
Air/Gas in Device	98	98
Material Separation	92	92
Loose or Intermittent Connection	51	51
Particulates	45	45
Infusion or Flow Problem	45	45
Connection Problem	45	45
Detachment of Device or Device Component	38	38
Separation Problem	34	34
Backflow	33	33
Defective Component	25	25
Obstruction of Flow	20	20
Fitting Problem	14	14
Difficult to Open or Close	14	14
Complete Blockage	13	13
Contamination	13	13
Fracture	13	13
Packaging Problem	13	13
Material Split, Cut or Torn	12	12
Physical Resistance/Sticking	10	10
Excess Flow or Over-Infusion	10	10
Material Puncture/Hole	10	10
Free or Unrestricted Flow	8	8
Separation Failure	8	8
Inaccurate Delivery	7	7
Delivered as Unsterile Product	7	7
Incomplete or Inadequate Connection	7	7
Material Twisted/Bent	7	7
Material Deformation	6	6
Device Markings/Labelling Problem	6	6
Gas/Air Leak	6	6
Defective Device	5	5
Unsealed Device Packaging	5	5
Insufficient Flow or Under Infusion	5	5
Inaccurate Flow Rate	5	5
Component Missing	4	4
Mechanical Problem	4	4
Material Rupture	3	3
Inaccurate Information	3	3
Mechanical Jam	3	3
Failure to Deliver	3	3
Microbial Contamination of Device	3	3
Device Damaged Prior to Use	2	2
Flushing Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1890	1890
No Consequences Or Impact To Patient	221	221
Insufficient Information	97	97
Chemical Exposure	96	96
Low Blood Pressure/ Hypotension	71	71
No Known Impact Or Consequence To Patient	63	63
No Patient Involvement	38	38
Hemorrhage/Bleeding	34	34
Air Embolism	8	8
Blood Loss	8	8
Hypoglycemia	6	6
High Blood Pressure/ Hypertension	5	5
Low Oxygen Saturation	5	5
Sepsis	5	5
Awareness during Anaesthesia	5	5
Cardiac Arrest	5	5
Death	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Information	3	3
Skin Burning Sensation	2	2
Loss of consciousness	2	2
Tachycardia	2	2
Discomfort	2	2
Exposure to Body Fluids	2	2
Emotional Changes	2	2
Stroke/CVA	2	2
Ventricular Fibrillation	1	1
Thrombosis/Thrombus	1	1
Cardiogenic Shock	1	1
Burning Sensation	1	1
Loss Of Pulse	1	1
Overdose	1	1
Cardiopulmonary Arrest	1	1
Blister	1	1
Embolism/Embolus	1	1
Malaise	1	1
Shaking/Tremors	1	1
Underdose	1	1
Radiation Overdose	1	1
Hypoxia	1	1
Missed Dose	1	1
Infiltration into Tissue	1	1
Hypersensitivity/Allergic reaction	1	1
Bacterial Infection	1	1
Irritability	1	1
Extreme Exhaustion	1	1
Respiratory Failure	1	1
Ventilator Dependent	1	1
Unintended Radiation Exposure	1	1
Patient Problem/Medical Problem	1	1