TPLC - Total Product Life Cycle

show TPLC since

Device	device, warming. blood and plasma
Product Code	KZL
Regulation Number	864.9205
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	114	114
Leak/Splash	78	78
Break	13	13
Infusion or Flow Problem	13	13
Connection Problem	12	12
Component Missing	9	9
Device Damaged Prior to Use	7	7
Improper Flow or Infusion	6	6
Obstruction of Flow	5	5
Detachment of Device or Device Component	5	5
Crack	5	5
Defective Component	4	4
Disconnection	3	3
No Pressure	3	3
Material Split, Cut or Torn	3	3
Pressure Problem	3	3
Audible Prompt/Feedback Problem	2	2
Positioning Problem	2	2
Device Alarm System	2	2
Partial Blockage	2	2
Loose or Intermittent Connection	2	2
Mechanical Problem	2	2
Misassembled	2	2
Material Separation	2	2
Structural Problem	2	2
Defective Device	2	2
Deformation Due to Compressive Stress	2	2
Material Deformation	2	2
Material Twisted/Bent	1	1
No Flow	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Free or Unrestricted Flow	1	1
Failure to Align	1	1
Failure to Infuse	1	1
Tear, Rip or Hole in Device Packaging	1	1
Insufficient Flow or Under Infusion	1	1
Fracture	1	1
Insufficient Heating	1	1
Failure to Prime	1	1
Loss of or Failure to Bond	1	1
Contamination	1	1
Unintended Ejection	1	1
Inaccurate Flow Rate	1	1
Deflation Problem	1	1
Output Problem	1	1
Incomplete or Inadequate Connection	1	1
Priming Problem	1	1
Pumping Problem	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	206	206
No Consequences Or Impact To Patient	25	25
No Patient Involvement	23	23
Insufficient Information	16	16
No Information	11	11
Death	7	7
Low Blood Pressure/ Hypotension	3	3
Hypothermia	3	3
No Known Impact Or Consequence To Patient	3	3
Patient Problem/Medical Problem	1	1
Abdominal Distention	1	1