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	59	59

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	80	80
Crack	78	78
Mechanical Problem	30	30
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	13	13
Deformation Due to Compressive Stress	13	13
Leak/Splash	12	12
Optical Problem	9	9
Device Alarm System	8	8
Gas/Air Leak	8	8
Noise, Audible	8	8
Material Puncture/Hole	8	8
Appropriate Term/Code Not Available	8	8
Electrical /Electronic Property Problem	7	7
Suction Problem	6	6
Infusion or Flow Problem	5	5
Contamination /Decontamination Problem	5	5
No Apparent Adverse Event	5	5
Improper or Incorrect Procedure or Method	4	4
Break	4	4
Material Twisted/Bent	4	4
Delivered as Unsterile Product	3	3
Material Discolored	3	3
Therapeutic or Diagnostic Output Failure	3	3
Physical Resistance/Sticking	3	3
Disconnection	3	3
Defective Device	3	3
Connection Problem	3	3
Smoking	3	3
Component Missing	3	3
Fracture	2	2
Thermal Decomposition of Device	2	2
Defective Component	2	2
Use of Device Problem	2	2
Burst Container or Vessel	2	2
Self-Activation or Keying	2	2
Contamination	2	2
Loose or Intermittent Connection	2	2
Protective Measures Problem	1	1
Microbial Contamination of Device	1	1
Device Contamination with Body Fluid	1	1
Device Markings/Labelling Problem	1	1
Unsealed Device Packaging	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	184	184
No Known Impact Or Consequence To Patient	60	60
Hemorrhage/Bleeding	43	43
No Patient Involvement	31	31
No Consequences Or Impact To Patient	29	29
Insufficient Information	15	15
Unspecified Blood or Lymphatic problem	12	12
No Information	8	8
Death	8	8
Blood Loss	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Hypovolemia	5	5
Cardiac Arrest	3	3
Hemolysis	3	3
Pneumothorax	3	3
Low Blood Pressure/ Hypotension	2	2
Low Cardiac Output	2	2
Foreign Body In Patient	2	2
Respiratory Distress	2	2
Thrombosis/Thrombus	2	2
Pleural Effusion	2	2
Bradycardia	1	1
Sudden Cardiac Death	1	1
Low Oxygen Saturation	1	1
Unspecified Infection	1	1
No Code Available	1	1
Air Embolism	1	1
Dyspnea	1	1
Blister	1	1
Local Reaction	1	1
Thrombus	1	1
Pulmonary Embolism	1	1
Ruptured Aneurysm	1	1
Skin Tears	1	1
Cough	1	1
Unspecified Heart Problem	1	1
Hemothorax	1	1
Cognitive Changes	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