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	205	205
Leak/Splash	86	86
Deformation Due to Compressive Stress	22	22
Break	18	18
Scratched Material	18	18
Connection Problem	15	15
Infusion or Flow Problem	14	14
Obstruction of Flow	14	14
Fitting Problem	13	13
Disconnection	9	9
Component Missing	9	9
Insufficient Flow or Under Infusion	8	8
Improper Flow or Infusion	8	8
Crack	7	7
Device Damaged Prior to Use	7	7
Material Separation	7	7
Detachment of Device or Device Component	6	6
Defective Component	6	6
Overheating of Device	5	5
Separation Problem	4	4
Fracture	4	4
Pressure Problem	3	3
Material Split, Cut or Torn	3	3
Mechanical Problem	3	3
Loose or Intermittent Connection	3	3
Device Alarm System	3	3
Excessive Heating	3	3
Free or Unrestricted Flow	3	3
Defective Device	3	3
No Pressure	3	3
Material Twisted/Bent	3	3
Priming Problem	2	2
Insufficient Heating	2	2
Failure to Prime	2	2
Partial Blockage	2	2
Material Deformation	2	2
Misassembled	2	2
Audible Prompt/Feedback Problem	2	2
Material Too Rigid or Stiff	2	2
Backflow	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Deflation Problem	2	2
No Audible Alarm	2	2
Positioning Problem	2	2
Collapse	2	2
Complete Blockage	2	2
Failure to Align	1	1
Unintended Ejection	1	1
Inaccurate Flow Rate	1	1
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	366	366
Insufficient Information	32	32
No Consequences Or Impact To Patient	25	25
No Patient Involvement	23	23
No Information	10	10
Death	6	6
Hypothermia	3	3
Low Blood Pressure/ Hypotension	3	3
Hypovolemic Shock	1	1
Patient Problem/Medical Problem	1	1
Abdominal Distention	1	1
Cardiac Arrest	1	1