TPLC - Total Product Life Cycle

show TPLC since

Device	tubing, pump, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass pump tubing.
Product Code	DWE
Regulation Number	870.4390
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	411	418
Obstruction of Flow	67	67
Material Separation	66	68
Air/Gas in Device	57	59
Material Puncture/Hole	54	56
Crack	41	43
Material Deformation	39	39
Disconnection	37	37
Misassembled During Installation	31	31
Tear, Rip or Hole in Device Packaging	13	13
Component Missing	12	13
Mechanical Problem	12	12
Delivered as Unsterile Product	11	11
Misassembled	9	10
Leak/Splash	8	8
Noise, Audible	7	7
Component Misassembled	7	7
Break	7	7
Material Split, Cut or Torn	7	7
Packaging Problem	7	7
Increase in Pressure	6	6
Detachment of Device or Device Component	6	6
Fracture	5	6
No Apparent Adverse Event	4	4
Gas/Air Leak	4	4
Material Twisted/Bent	4	4
No Flow	3	3
Defective Component	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Contamination	3	3
Difficult to Remove	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Decoupling	3	3
Infusion or Flow Problem	3	3
Mechanical Jam	2	2
Chemical Problem	2	2
Decrease in Pressure	2	2
Output Problem	2	2
Insufficient Information	2	2
Adverse Event Without Identified Device or Use Problem	1	1
Device Slipped	1	1
Device Difficult to Setup or Prepare	1	1
Compatibility Problem	1	1
Contamination /Decontamination Problem	1	1
Material Integrity Problem	1	1
Product Quality Problem	1	1
Free or Unrestricted Flow	1	1
Entrapment of Device	1	1
Pumping Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	669	675
Hemorrhage/Bleeding	115	118
Insufficient Information	12	12
Air Embolism	7	7
No Consequences Or Impact To Patient	6	6
Hypovolemia	5	5
Hypoxia	2	2
Low Blood Pressure/ Hypotension	2	2
Low Oxygen Saturation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hemolysis	1	1
Adult Respiratory Distress Syndrome	1	1
Embolism/Embolus	1	1
Pericardial Effusion	1	1
Cardiac Perforation	1	1
Paralysis	1	1
Bradycardia	1	1
Heart Failure/Congestive Heart Failure	1	1
Internal Organ Perforation	1	1
Ischemia Stroke	1	1