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	23	23

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	369	379
Disconnection	151	156
No Flow	47	47
Break	42	42
Crack	40	40
Leak/Splash	36	36
Filling Problem	31	31
Device Operates Differently Than Expected	30	30
Device Contamination with Chemical or Other Material	25	25
Failure to Prime	25	25
Material Puncture/Hole	21	21
Hole In Material	19	19
Detachment Of Device Component	18	18
Detachment of Device or Device Component	16	16
Material Deformation	16	16
Backflow	14	14
Connection Problem	13	13
Cut In Material	12	12
Failure to Disconnect	10	10
Device Displays Incorrect Message	10	10
Improper Flow or Infusion	10	11
Air Leak	10	10
Material Split, Cut or Torn	10	10
Material Separation	9	9
Component Missing	9	9
Failure to Infuse	8	8
Fitting Problem	8	8
Infusion or Flow Problem	7	7
Reflux within Device	7	7
Defective Component	6	6
Obstruction of Flow	5	5
Kinked	5	5
Melted	5	5
Complete Blockage	5	5
Fracture	4	4
Material Rupture	4	4
Improper or Incorrect Procedure or Method	4	4
Material Perforation	4	4
Material Twisted/Bent	4	4
Protective Measures Problem	4	4
Scratched Material	3	3
Air/Gas in Device	3	3
Material Integrity Problem	3	3
Contamination /Decontamination Problem	3	3
Free or Unrestricted Flow	3	3
Defective Device	3	3
Separation Failure	2	2
Device Damaged Prior to Use	2	2
Tear, Rip or Hole in Device Packaging	2	2
Insufficient Flow or Under Infusion	2	2
Misconnection	2	2
Occlusion Within Device	2	2
Excess Flow or Over-Infusion	2	2
Loose or Intermittent Connection	2	2
Mechanical Problem	2	2
Partial Blockage	2	2
Component Falling	2	2
Component Misassembled	2	2
Physical Resistance/Sticking	2	2
Incomplete or Inadequate Connection	1	1
Incomplete or Inadequate Priming	1	1
Difficult or Delayed Separation	1	1
Torn Material	1	1
Unintended Movement	1	1
Contamination	1	1
Material Discolored	1	1
Clumping in Device or Device Ingredient	1	1
Gas Output Problem	1	1
Inflation Problem	1	1
Difficult to Flush	1	1
Unsealed Device Packaging	1	1
Particulates	1	1
Device Difficult to Setup or Prepare	1	1
Difficult to Remove	1	1
Product Quality Problem	1	1
Failure to Deliver	1	1
Microbial Contamination of Device	1	1
Structural Problem	1	1
Patient-Device Incompatibility	1	1
Aspiration Issue	1	1
Device Packaging Compromised	1	1
Component or Accessory Incompatibility	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Material Protrusion/Extrusion	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1

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	189	189
No Known Impact Or Consequence To Patient	145	152
Insufficient Information	9	9
Low Blood Pressure/ Hypotension	4	4
Exposure to Body Fluids	3	3
No Information	3	3
Blood Loss	3	3
Cardiac Arrest	2	2
Death	1	1
Dyspnea	1	1
Hemorrhage/Bleeding	1	1
Bradycardia	1	1
Inflammation	1	1
Overdose	1	1
No Code Available	1	1
Respiratory Arrest	1	1
Discomfort	1	1
Reaction	1	1
Low Oxygen Saturation	1	1
Shaking/Tremors	1	1

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