TPLC - Total Product Life Cycle

• Device: infusor, pressure, for i.v. bags
• Product Code: KZD
• Regulation Number: 880.5420
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	6	6
2019	4	4
2020	8	8
2021	13	13
2022	45	45

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	24	24
Pressure Problem	17	17
Gas/Air Leak	4	4
Unintended Deflation	4	4
Decrease in Pressure	4	4
Defective Device	3	3
Mechanical Problem	3	3
Disconnection	3	3
Break	2	2
Burst Container or Vessel	2	2
Detachment of Device or Device Component	2	2
Device Handling Problem	2	2
Infusion or Flow Problem	2	2
Material Integrity Problem	2	2
Inflation Problem	2	2
Misassembly by Users	1	1
Appropriate Term/Code Not Available	1	1
Material Split, Cut or Torn	1	1
Air/Gas in Device	1	1
Device Operational Issue	1	1
Free or Unrestricted Flow	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Insufficient Flow or Under Infusion	1	1
Component Missing	1	1
Device Issue	1	1
Obstruction of Flow	1	1
Air Leak	1	1
Backflow	1	1
No Display/Image	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	52	52
Insufficient Information	8	8
No Known Impact Or Consequence To Patient	6	6
Urinary Tract Infection	2	2
No Code Available	2	2
Missing Value Reason	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Patient Involvement	1	1
Not Applicable	1	1
Air Embolism	1	1
Arrhythmia	1	1
Cardiac Arrest	1	1
Death	1	1
Hearing Impairment	1	1