TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	190	190
Leak/Splash	83	83
Deformation Due to Compressive Stress	22	22
Scratched Material	18	18
Break	17	17
Connection Problem	15	15
Infusion or Flow Problem	14	14
Fitting Problem	12	12
Obstruction of Flow	11	11
Component Missing	9	9
Disconnection	8	8
Improper Flow or Infusion	8	8
Material Separation	7	7
Crack	7	7
Device Damaged Prior to Use	7	7
Insufficient Flow or Under Infusion	6	6
Detachment of Device or Device Component	6	6
Defective Component	6	6
Overheating of Device	5	5
Fracture	4	4
Separation Problem	4	4
Material Twisted/Bent	3	3
No Pressure	3	3
Pressure Problem	3	3
Mechanical Problem	3	3
Material Split, Cut or Torn	3	3
Excessive Heating	3	3
Loose or Intermittent Connection	3	3
Defective Device	3	3
Free or Unrestricted Flow	3	3
Device Alarm System	3	3
Collapse	2	2
Partial Blockage	2	2
No Audible Alarm	2	2
Insufficient Heating	2	2
Priming Problem	2	2
Audible Prompt/Feedback Problem	2	2
Misassembled	2	2
Positioning Problem	2	2
Material Deformation	2	2
Device Contamination with Body Fluid	1	1
Inaccurate Delivery	1	1
Failure to Infuse	1	1
Tear, Rip or Hole in Device Packaging	1	1
Inadequacy of Device Shape and/or Size	1	1
Failure to Prime	1	1
Failure to Pump	1	1
Failure to Sense	1	1
Material Too Rigid or Stiff	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	340	340
Insufficient Information	31	31
No Consequences Or Impact To Patient	25	25
No Patient Involvement	23	23
No Information	10	10
Death	6	6
Low Blood Pressure/ Hypotension	3	3
Hypothermia	3	3
Hypovolemic Shock	1	1
Abdominal Distention	1	1
Patient Problem/Medical Problem	1	1