TPLC - Total Product Life Cycle

• Device: infusor, pressure, for i.v. bags
• Regulation Description: Pressure infusor for an I.V. bag.
• Product Code: KZD
• Regulation Number: 880.5420
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	8	8
2021	13	13
2022	45	45
2023	31	31
2024	43	43
2025	14	14

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	30	30
Leak/Splash	29	29
Pressure Problem	15	15
Material Integrity Problem	14	14
Material Split, Cut or Torn	11	11
Disconnection	8	8
Unintended Deflation	7	7
Inflation Problem	6	6
Device Markings/Labelling Problem	5	5
Mechanical Problem	5	5
Decrease in Pressure	5	5
Break	4	4
Crack	4	4
Detachment of Device or Device Component	4	4
Defective Device	3	3
Tear, Rip or Hole in Device Packaging	3	3
Fluid/Blood Leak	3	3
Fracture	3	3
Burst Container or Vessel	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Inaccurate Delivery	2	2
Infusion or Flow Problem	2	2
Insufficient Information	2	2
Device Handling Problem	2	2
Incomplete or Inadequate Connection	2	2
Failure to Deflate	1	1
Air/Gas in Device	1	1
Explosion	1	1
Appropriate Term/Code Not Available	1	1
Inadequate User Interface	1	1
Connection Problem	1	1
Obstruction of Flow	1	1
Backflow	1	1
Material Rupture	1	1
Use of Device Problem	1	1
Failure to Zero	1	1
Insufficient Flow or Under Infusion	1	1
Contamination	1	1
Deflation Problem	1	1
Material Fragmentation	1	1
No Display/Image	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	116	116
Insufficient Information	27	27
Air Embolism	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Urinary Tract Infection	2	2
Hearing Impairment	1	1
Arrhythmia	1	1
Not Applicable	1	1
Respiratory Arrest	1	1
Embolism/Embolus	1	1
Atrial Fibrillation	1	1
Cardiac Arrest	1	1
Foreign Body In Patient	1	1
Respiratory Insufficiency	1	1