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	208	210
Leak/Splash	65	65
Deformation Due to Compressive Stress	21	22
Scratched Material	18	18
Break	15	16
Connection Problem	15	15
Obstruction of Flow	14	15
Fitting Problem	13	13
Disconnection	9	10
Infusion or Flow Problem	9	9
Insufficient Flow or Under Infusion	8	8
Component Missing	8	8
Device Damaged Prior to Use	7	7
Crack	6	6
Detachment of Device or Device Component	6	6
Material Separation	6	6
Overheating of Device	5	5
Defective Component	5	5
Separation Problem	4	4
Fracture	4	5
Improper Flow or Infusion	4	4
Material Split, Cut or Torn	3	3
Device Alarm System	3	3
Excessive Heating	3	3
Defective Device	3	3
Material Twisted/Bent	3	3
Loose or Intermittent Connection	2	3
Priming Problem	2	2
Insufficient Heating	2	2
Free or Unrestricted Flow	2	2
Partial Blockage	2	4
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
Mechanical Problem	2	2
Unintended Ejection	1	1
Air/Gas in Device	1	1
Inaccurate Flow Rate	1	1
Contamination	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure to Sense	1	1
Failure to Prime	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	386	392
Insufficient Information	32	33
No Information	6	6
No Patient Involvement	4	4
No Consequences Or Impact To Patient	2	2
Hypovolemic Shock	1	1
Abdominal Distention	1	1
Cardiac Arrest	1	1