TPLC - Total Product Life Cycle

• Device: set, blood transfusion
• Product Code: BRZ
• Regulation Number: 880.5440
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ARTERIOCYTE MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAXTER HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	108	108
2015	171	171
2016	78	78
2017	82	82
2018	66	66
2019	85	99
2020	90	90
2021	60	60
2022	55	55
2023	67	67
2024	56	56

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	382	392
Disconnection	151	156
No Flow	48	48
Break	44	44
Crack	41	41
Leak/Splash	36	36
Filling Problem	35	35
Device Operates Differently Than Expected	30	30
Device Contamination with Chemical or Other Material	26	26
Failure to Prime	25	25
Detachment of Device or Device Component	22	22
Material Puncture/Hole	22	22
Hole In Material	19	19
Detachment Of Device Component	18	18
Backflow	16	16
Material Deformation	16	16
Connection Problem	13	13
Cut In Material	12	12
Improper Flow or Infusion	10	11
Air Leak	10	10
Device Displays Incorrect Message	10	10
Failure to Disconnect	10	10
Material Split, Cut or Torn	10	10
Component Missing	9	9
Material Separation	9	9
Failure to Infuse	8	8
Fitting Problem	8	8
Reflux within Device	7	7
Infusion or Flow Problem	7	7
Defective Component	6	6
Kinked	5	5
Complete Blockage	5	5
Obstruction of Flow	5	5
Improper or Incorrect Procedure or Method	5	5
Melted	5	5
Material Rupture	4	4
Air/Gas in Device	4	4
Protective Measures Problem	4	4
Material Twisted/Bent	4	4
Fracture	4	4
Material Perforation	4	4
Misconnection	3	3
Scratched Material	3	3
Material Integrity Problem	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Free or Unrestricted Flow	3	3
Component Falling	2	2
Tear, Rip or Hole in Device Packaging	2	2
Component Misassembled	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	263	268
No Patient Involvement	260	262
No Clinical Signs, Symptoms or Conditions	221	221
No Known Impact Or Consequence To Patient	145	152
Insufficient Information	10	10
Low Blood Pressure/ Hypotension	4	4
No Information	3	3
Blood Loss	3	3
Exposure to Body Fluids	3	3
Cardiac Arrest	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
No Code Available	1	1
Respiratory Arrest	1	1
Inflammation	1	1
Overdose	1	1
Discomfort	1	1
Dyspnea	1	1
Bradycardia	1	1
Reaction	1	1
Shaking/Tremors	1	1
Hemorrhage/Bleeding	1	1
Low Oxygen Saturation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Genesis BPS, LLC.	II	Sep-18-2014
2	Hospira Inc.	I	Aug-05-2013