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
1. K201068 Affinity CP Centrifugal Blood Pump, Affinity CP Ce ...
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	1
QURA S.R.L.
	SUBSTANTIALLY EQUIVALENT	4
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Electrical /Electronic Property Problem	445	445
Insufficient Information	236	236
Pumping Stopped	175	175
Adverse Event Without Identified Device or Use Problem	151	151
Noise, Audible	129	129
Infusion or Flow Problem	125	125
Mechanical Problem	113	113
Device Displays Incorrect Message	107	107
Battery Problem	78	78
Unexpected Shutdown	76	76
Overheating of Device	66	66
Inaccurate Flow Rate	47	47
Pumping Problem	35	35
Communication or Transmission Problem	28	28
Fluid/Blood Leak	22	22
No Apparent Adverse Event	19	19
Insufficient Flow or Under Infusion	18	18
Increased Pump Speed	18	18
Device Difficult to Setup or Prepare	17	17
No Flow	17	17
Decreased Pump Speed	17	17
Obstruction of Flow	12	12
Break	12	12
Excessive Heating	12	12
Failure to Power Up	11	11
Display or Visual Feedback Problem	11	11
Leak/Splash	11	11
Detachment of Device or Device Component	10	10
No Display/Image	10	10
Material Twisted/Bent	9	9
Premature Discharge of Battery	8	8
Failure to Pump	8	8
Material Deformation	8	8
Crack	8	8
Use of Device Problem	8	8
Electrical Power Problem	7	7
Product Quality Problem	7	7
Improper Flow or Infusion	7	7
Unexpected Therapeutic Results	6	6
Fracture	6	6
Loose or Intermittent Connection	6	6
Disconnection	6	6
Material Puncture/Hole	5	5
Gas/Air Leak	5	5
Device Sensing Problem	4	4
Labelling, Instructions for Use or Training Problem	4	4
Image Display Error/Artifact	4	4
Device Alarm System	4	4
Pressure Problem	4	4
Fitting Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1210	1210
No Consequences Or Impact To Patient	190	190
No Patient Involvement	140	140
Insufficient Information	106	106
No Known Impact Or Consequence To Patient	81	81
Hemorrhage/Bleeding	65	65
Thrombosis/Thrombus	45	45
Cardiac Arrest	30	30
Hemolysis	30	30
Heart Failure/Congestive Heart Failure	28	28
Death	24	24
Bacterial Infection	20	20
Low Oxygen Saturation	19	19
Multiple Organ Failure	16	16
Renal Failure	16	16
No Information	16	16
Arrhythmia	16	16
Thromboembolism	14	14
Ischemia Stroke	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Sepsis	11	11
Stroke/CVA	11	11
Hypoxia	11	11
Respiratory Failure	10	10
Unspecified Infection	10	10
Tachycardia	10	10
Atrial Fibrillation	10	10
Low Blood Pressure/ Hypotension	9	9
Cardiogenic Shock	9	9
Renal Impairment	8	8
Blood Loss	8	8
Thrombus	7	7
Fungal Infection	7	7
Intracranial Hemorrhage	5	5
Gastrointestinal Hemorrhage	5	5
Hematoma	5	5
Hemorrhagic Stroke	5	5
High Blood Pressure/ Hypertension	5	5
Anemia	5	5
Ventricular Fibrillation	4	4
Bradycardia	4	4
Lactate Dehydrogenase Increased	4	4
Ischemia	4	4
Respiratory Insufficiency	4	4
Brain Injury	4	4
Air Embolism	4	4
Obstruction/Occlusion	3	3
Hematuria	3	3
Respiratory Arrest	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