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
2014	72	72
2015	31	31
2016	4	4
2017	38	38
2018	6	6
2019	4	4
2020	8	8
2021	13	13
2022	45	45
2023	31	31
2024	26	26

Device Problems	MDRs with this Device Problem	Events in those MDRs
Air Leak	109	109
Loss of or Failure to Bond	93	93
Leak/Splash	44	44
Gas/Air Leak	23	23
Pressure Problem	20	20
Decrease in Pressure	15	15
Device Contamination with Chemical or Other Material	12	12
Crack	9	9
Inflation Problem	6	6
Unintended Deflation	6	6
Disconnection	5	5
Break	5	5
Appropriate Term/Code Not Available	5	5
Mechanical Problem	4	4
Missing Value Reason	4	4
Material Integrity Problem	4	4
Detachment of Device or Device Component	4	4
Fluid/Blood Leak	4	4
Device Operates Differently Than Expected	4	4
Burst Container or Vessel	3	3
Defective Device	3	3
Insufficient Information	3	3
Device Markings/Labelling Problem	3	3
Material Split, Cut or Torn	2	2
Deflation Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Device Handling Problem	2	2
Detachment Of Device Component	2	2
Backflow	2	2
Infusion or Flow Problem	2	2
Inaccurate Delivery	2	2
Fracture	2	2
Device Issue	1	1
Explosion	1	1
Free or Unrestricted Flow	1	1
Obstruction of Flow	1	1
Use of Device Problem	1	1
Component Missing	1	1
Improper Flow or Infusion	1	1
Torn Material	1	1
Insufficient Flow or Under Infusion	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Fragmentation	1	1
Component Falling	1	1
Inadequate User Interface	1	1
Failure to Deflate	1	1
Material Rupture	1	1
Misassembly by Users	1	1
Air/Gas in Device	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	109	109
No Clinical Signs, Symptoms or Conditions	86	86
Insufficient Information	26	26
No Consequences Or Impact To Patient	25	25
No Code Available	6	6
No Information	6	6
Missing Value Reason	6	6
Air Embolism	5	5
No Patient Involvement	3	3
Low Blood Pressure/ Hypotension	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Death	2	2
Cardiac Arrest	2	2
Urinary Tract Infection	2	2
Hearing Impairment	1	1
Arrhythmia	1	1
Not Applicable	1	1
Respiratory Arrest	1	1
Misdiagnosis	1	1
Embolism/Embolus	1	1
Atrial Fibrillation	1	1
Foreign Body In Patient	1	1
Sudden Cardiac Death	1	1
Respiratory Insufficiency	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Jun-26-2017
2	GE Healthcare, LLC	II	Jun-24-2011
3	Merit Medical Systems, Inc.	II	Dec-14-2009