TPLC - Total Product Life Cycle

show TPLC since

Device	pump, blood, cardiopulmonary bypass, non-roller type
Regulation Description	Nonroller-type blood pump.
Product Code	KFM
Regulation Number	870.4360
Device Class	2

Premarket Reviews
Manufacturer	Decision
CARDIACASSIST, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL BIOPHYSICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	5
SPECTRUM MEDICAL S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Electrical /Electronic Property Problem	508	509
Insufficient Information	249	251
Pumping Stopped	198	198
Adverse Event Without Identified Device or Use Problem	151	158
Noise, Audible	148	148
Infusion or Flow Problem	129	131
Mechanical Problem	117	118
Device Displays Incorrect Message	107	107
Battery Problem	90	91
Unexpected Shutdown	79	79
Overheating of Device	72	72
Inaccurate Flow Rate	47	47
Pumping Problem	35	36
Communication or Transmission Problem	31	31
Fluid/Blood Leak	30	32
No Apparent Adverse Event	20	21
Device Difficult to Setup or Prepare	20	20
Increased Pump Speed	18	18
Insufficient Flow or Under Infusion	18	18
Decreased Pump Speed	18	18
Obstruction of Flow	17	17
Crack	17	18
Break	17	18
No Flow	16	16
Display or Visual Feedback Problem	12	12
Material Deformation	12	13
Failure to Power Up	12	13
Excessive Heating	11	11
Improper Flow or Infusion	11	11
Leak/Splash	11	11
No Display/Image	10	10
Detachment of Device or Device Component	10	10
Material Twisted/Bent	9	9
Premature Discharge of Battery	8	8
Failure to Pump	8	8
Use of Device Problem	8	8
Electrical Power Problem	7	7
Loose or Intermittent Connection	7	7
Material Puncture/Hole	7	7
Fracture	7	7
Product Quality Problem	6	6
Unexpected Therapeutic Results	6	6
Gas/Air Leak	6	6
Disconnection	6	6
Temperature Problem	5	5
Labelling, Instructions for Use or Training Problem	4	4
Decoupling	4	4
Device Sensing Problem	4	4
Partial Blockage	4	4
Air/Gas in Device	4	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1335	1345
No Consequences Or Impact To Patient	190	190
No Patient Involvement	139	139
Insufficient Information	115	115
No Known Impact Or Consequence To Patient	81	81
Hemorrhage/Bleeding	67	71
Thrombosis/Thrombus	45	46
Cardiac Arrest	34	34
Hemolysis	32	33
Heart Failure/Congestive Heart Failure	26	30
Death	24	24
Bacterial Infection	21	21
Low Oxygen Saturation	20	20
No Information	16	16
Multiple Organ Failure	15	15
Renal Failure	15	15
Ischemia Stroke	15	15
Arrhythmia	15	17
Thromboembolism	14	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Unspecified Infection	12	12
Sepsis	11	11
Low Blood Pressure/ Hypotension	10	11
Respiratory Failure	10	10
Stroke/CVA	10	11
Atrial Fibrillation	10	11
Tachycardia	10	11
Cardiogenic Shock	9	9
Air Embolism	9	9
Hypoxia	9	9
Renal Impairment	8	9
Blood Loss	8	8
Thrombus	7	7
Fungal Infection	7	7
Hemorrhagic Stroke	7	7
High Blood Pressure/ Hypertension	6	6
Gastrointestinal Hemorrhage	6	6
Hematoma	5	5
Anemia	5	5
Intracranial Hemorrhage	5	6
Septic Shock	5	5
Ischemia	4	4
Bradycardia	4	4
Lactate Dehydrogenase Increased	4	4
Ventricular Fibrillation	4	4
Respiratory Insufficiency	4	4
Encephalopathy	3	3
Obstruction/Occlusion	3	3
Hematuria	3	3
Hypovolemia	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardiac Assist, Inc	II	Aug-25-2023
2	Cardiac Assist, Inc	II	May-11-2020
3	Maquet Cardiovascular Us Sales, Llc	III	Sep-12-2020
4	Maquet Medical Systems USA	II	Feb-02-2024
5	OriGen Biomedical, Inc.	II	Oct-30-2020
6	QURA S.R.L.	II	Aug-12-2021
7	Spectrum Medical Inc	II	Mar-13-2025