TPLC - Total Product Life Cycle

• Device: apparatus, autotransfusion
• Product Code: CAC
• Regulation Number: 868.5830
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ATRIUM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS KABI AG
	SUBSTANTIALLY EQUIVALENT	2
HAEMONETICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INARI MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
INARI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
INQUIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PROCELL SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SISU GLOBAL HEALTH
	SUBSTANTIALLY EQUIVALENT	1
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	64	64
2020	108	108
2021	73	73
2022	65	65
2023	39	39
2024	75	75

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	92	92
Crack	79	79
Mechanical Problem	31	31
Material Integrity Problem	29	29
Insufficient Information	18	18
Adverse Event Without Identified Device or Use Problem	17	17
Device Misassembled During Manufacturing /Shipping	15	15
Obstruction of Flow	15	15
Nonstandard Device	15	15
Material Deformation	14	14
Deformation Due to Compressive Stress	13	13
Leak/Splash	12	12
Electrical /Electronic Property Problem	10	10
Optical Problem	10	10
Gas/Air Leak	8	8
Device Alarm System	8	8
Material Puncture/Hole	8	8
Appropriate Term/Code Not Available	8	8
Noise, Audible	8	8
Suction Problem	6	6
Contamination /Decontamination Problem	5	5
Infusion or Flow Problem	5	5
No Apparent Adverse Event	5	5
Improper or Incorrect Procedure or Method	4	4
Material Twisted/Bent	4	4
Break	4	4
Material Discolored	3	3
Disconnection	3	3
Delivered as Unsterile Product	3	3
Smoking	3	3
Therapeutic or Diagnostic Output Failure	3	3
Connection Problem	3	3
Component Missing	3	3
Defective Device	3	3
Physical Resistance/Sticking	3	3
Air/Gas in Device	3	3
Defective Component	2	2
Use of Device Problem	2	2
Self-Activation or Keying	2	2
Thermal Decomposition of Device	2	2
Burst Container or Vessel	2	2
Contamination	2	2
Loose or Intermittent Connection	2	2
Fracture	2	2
Excess Flow or Over-Infusion	1	1
Inadequate Instructions for Healthcare Professional	1	1
Incorrect Measurement	1	1
Filling Problem	1	1
Decrease in Suction	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	198	198
No Known Impact Or Consequence To Patient	60	60
Hemorrhage/Bleeding	46	46
No Patient Involvement	31	31
No Consequences Or Impact To Patient	29	29
Insufficient Information	15	15
Unspecified Blood or Lymphatic problem	12	12
Death	8	8
No Information	8	8
Blood Loss	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Hypovolemia	5	5
Pneumothorax	3	3
Hemolysis	3	3
Cardiac Arrest	3	3
Respiratory Distress	2	2
Low Cardiac Output	2	2
Foreign Body In Patient	2	2
Thrombosis/Thrombus	2	2
Pleural Effusion	2	2
Low Blood Pressure/ Hypotension	2	2
Air Embolism	1	1
Unspecified Infection	1	1
No Code Available	1	1
Local Reaction	1	1
Cognitive Changes	1	1
Blister	1	1
Dyspnea	1	1
Bradycardia	1	1
Renal Failure	1	1
Sudden Cardiac Death	1	1
Cough	1	1
Skin Tears	1	1
Ruptured Aneurysm	1	1
Unspecified Heart Problem	1	1
Hemothorax	1	1
Thrombus	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Aspiration Pneumonitis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	II	Dec-28-2023
2	Atrium Medical Corporation	II	Dec-02-2023
3	Atrium Medical Corporation	II	Nov-16-2023
4	Fenwal Inc	II	Apr-23-2019
5	Fenwal Inc	II	Mar-26-2019
6	Haemonetics Corporation	II	Jan-29-2020
7	Haemonetics Corporation	II	Jan-28-2019
8	Maquet Cardiovascular, LLC	I	Jan-12-2024
9	Medtronic Perfusion Systems	II	Jan-29-2019