TPLC - Total Product Life Cycle

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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	556	557
Insufficient Device Problem Information	276	278
Pumping Stopped	232	232
Adverse Event Without Identified Device or Use Problem	154	161
Noise, Audible	153	153
Infusion or Flow Problem	136	138
Mechanical Problem	126	127
Device Displays Incorrect Message	105	105
Battery Problem	100	101
Unexpected Shutdown	81	81
Overheating of Device	72	72
Inaccurate Flow Rate	48	48
Pumping Problem	36	37
Communication or Transmission Problem	32	32
Fluid/Blood Leak	30	32
Device Difficult to Setup or Prepare	26	26
No Apparent Adverse Event	23	24
Crack	20	21
Obstruction of Flow	20	20
Break	19	20
Decreased Pump Speed	18	18
Insufficient Flow or Under Infusion	18	18
Increased Pump Speed	18	18
Failure to Power Up	15	16
No Flow	14	14
Material Deformation	14	15
No Display/Image	12	12
Display or Visual Feedback Problem	11	11
Excessive Heating	11	11
Detachment of Device or Device Component	11	11
Improper Flow or Infusion	11	11
Leak/Splash	10	10
Premature Discharge of Battery	9	9
Material Twisted/Bent	8	8
Material Puncture/Hole	8	8
Electrical Power Problem	7	7
Use of Device Problem	7	7
Failure to Pump	7	7
Disconnection	6	6
Product Quality Problem	6	6
Temperature Problem	6	6
Fracture	6	6
Loose or Intermittent Connection	6	6
Unexpected Therapeutic Results	6	6
Failure to Run on Battery	5	5
Fitting Problem	4	4
Gas/Air Leak	4	4
Labelling, Instructions for Use or Training Problem	4	4
Backflow	4	4
Partial Blockage	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1469	1479
No Consequences Or Impact To Patient	190	190
No Patient Involvement	139	139
Insufficient Information	120	120
No Known Impact Or Consequence To Patient	81	81
Hemorrhage/Blood Loss/Bleeding	70	74
Thrombosis/Thrombus	45	46
Cardiac Arrest	38	38
Hemolysis	33	34
Heart Failure/Congestive Heart Failure	26	30
Death	24	24
Bacterial Infection	21	21
Low Oxygen Saturation	20	20
No Information	16	16
Ischemia Stroke	15	15
Renal Failure	15	15
Multiple Organ Dysfunction Syndrome	15	15
Arrhythmia	15	17
Thromboembolism	14	15
Low Blood Pressure/ Hypotension	14	15
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	13	13
Unspecified Infection	12	12
Hypoxia	12	12
Sepsis	11	11
Atrial Fibrillation	10	11
Stroke/CVA	10	11
Respiratory Failure	10	10
Tachycardia	10	11
Cardiogenic Shock	9	9
Renal Impairment	8	9
Blood Loss	8	8
Hemorrhagic Stroke	7	7
Fungal Infection	7	7
Air Embolism	7	7
Thrombus	7	7
Gastrointestinal Hemorrhage	6	6
High Blood Pressure/ Hypertension	6	6
Anemia	5	5
Hematoma	5	5
Septic Shock	5	5
Hemodynamic instability	5	5
Intracranial Hemorrhage	5	6
Coagulation Disorder	4	4
Ischemia	4	4
Respiratory Insufficiency	4	4
Bradycardia	4	4
Ventricular Fibrillation	4	4
Lactate Dehydrogenase Increased	4	4
Hypovolemia	3	3
Respiratory Arrest	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