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	1
QURA S.R.L.
	SUBSTANTIALLY EQUIVALENT	4
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	505	505
Insufficient Information	245	245
Pumping Stopped	197	197
Adverse Event Without Identified Device or Use Problem	151	151
Noise, Audible	145	145
Infusion or Flow Problem	127	127
Mechanical Problem	116	116
Device Displays Incorrect Message	107	107
Battery Problem	88	88
Unexpected Shutdown	79	79
Overheating of Device	70	70
Inaccurate Flow Rate	47	47
Pumping Problem	35	35
Communication or Transmission Problem	31	31
Fluid/Blood Leak	30	30
No Apparent Adverse Event	20	20
Device Difficult to Setup or Prepare	19	19
Increased Pump Speed	18	18
Insufficient Flow or Under Infusion	18	18
Decreased Pump Speed	18	18
Obstruction of Flow	17	17
Crack	17	17
No Flow	16	16
Break	16	16
Display or Visual Feedback Problem	12	12
Material Deformation	12	12
Failure to Power Up	12	12
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	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1325	1325
No Consequences Or Impact To Patient	190	190
No Patient Involvement	139	139
Insufficient Information	111	111
No Known Impact Or Consequence To Patient	81	81
Hemorrhage/Bleeding	67	67
Thrombosis/Thrombus	45	45
Cardiac Arrest	34	34
Hemolysis	32	32
Heart Failure/Congestive Heart Failure	26	26
Death	24	24
Bacterial Infection	21	21
Low Oxygen Saturation	20	20
No Information	16	16
Renal Failure	15	15
Arrhythmia	15	15
Multiple Organ Failure	15	15
Ischemia Stroke	15	15
Thromboembolism	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Unspecified Infection	12	12
Sepsis	11	11
Tachycardia	10	10
Stroke/CVA	10	10
Atrial Fibrillation	10	10
Low Blood Pressure/ Hypotension	10	10
Respiratory Failure	10	10
Hypoxia	9	9
Cardiogenic Shock	9	9
Air Embolism	9	9
Renal Impairment	8	8
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
Septic Shock	5	5
Anemia	5	5
Intracranial Hemorrhage	5	5
Bradycardia	4	4
Lactate Dehydrogenase Increased	4	4
Ischemia	4	4
Respiratory Insufficiency	4	4
Ventricular Fibrillation	4	4
Encephalopathy	3	3
Dyspnea	3	3
Liver Failure	3	3
Obstruction/Occlusion	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