TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
CARDIACASSIST INC
	SUBSTANTIALLY EQUIVALENT	1
CARDIACASSIST, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL BIOPHYSICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	1
QURA S.R.L.
	SUBSTANTIALLY EQUIVALENT	4
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Electrical /Electronic Property Problem	385	385
Insufficient Information	234	234
Pumping Stopped	189	189
Adverse Event Without Identified Device or Use Problem	187	187
Noise, Audible	179	179
Infusion or Flow Problem	126	126
Device Displays Incorrect Message	119	119
Mechanical Problem	117	117
Overheating of Device	92	92
Battery Problem	82	82
Unexpected Shutdown	82	82
Communication or Transmission Problem	50	50
Inaccurate Flow Rate	41	41
Pumping Problem	37	37
No Flow	26	26
Decreased Pump Speed	26	26
Fluid/Blood Leak	23	23
Insufficient Flow or Under Infusion	22	22
Device Difficult to Setup or Prepare	19	19
Increased Pump Speed	18	18
No Apparent Adverse Event	18	18
No Display/Image	17	17
Break	16	16
Excessive Heating	16	16
Material Twisted/Bent	16	16
Disconnection	14	14
Display or Visual Feedback Problem	14	14
Obstruction of Flow	12	12
Electrical Power Problem	12	12
Use of Device Problem	11	11
Leak/Splash	11	11
Crack	11	11
Failure to Pump	10	10
Failure to Power Up	10	10
Detachment of Device or Device Component	10	10
Power Problem	10	10
Premature Discharge of Battery	8	8
Loose or Intermittent Connection	7	7
Vibration	7	7
Connection Problem	7	7
Improper Flow or Infusion	7	7
Unexpected Therapeutic Results	6	6
Material Deformation	6	6
Fitting Problem	6	6
Loss of Power	6	6
Product Quality Problem	6	6
Fracture	6	6
Device Alarm System	5	5
Erratic or Intermittent Display	5	5
Temperature Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1094	1094
No Consequences Or Impact To Patient	281	281
No Patient Involvement	205	205
No Known Impact Or Consequence To Patient	175	175
Insufficient Information	102	102
Hemorrhage/Bleeding	63	63
Thrombosis/Thrombus	44	44
Death	42	42
Hemolysis	35	35
Cardiac Arrest	31	31
Heart Failure/Congestive Heart Failure	28	28
No Information	22	22
Thrombus	21	21
Low Oxygen Saturation	20	20
Arrhythmia	18	18
Bacterial Infection	18	18
Renal Failure	17	17
Multiple Organ Failure	15	15
Thromboembolism	14	14
Blood Loss	13	13
Ischemia Stroke	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Hypoxia	11	11
Unspecified Infection	11	11
Tachycardia	10	10
Stroke/CVA	10	10
Cardiogenic Shock	10	10
Low Blood Pressure/ Hypotension	10	10
Respiratory Failure	10	10
Sepsis	9	9
Atrial Fibrillation	9	9
Renal Impairment	8	8
Fungal Infection	7	7
Intracranial Hemorrhage	6	6
Hematoma	6	6
Gastrointestinal Hemorrhage	5	5
Hemorrhagic Stroke	5	5
Anemia	5	5
Reaction	4	4
Bradycardia	4	4
Lactate Dehydrogenase Increased	4	4
Dyspnea	4	4
Right Ventricular Failure	4	4
Respiratory Insufficiency	4	4
Ventricular Fibrillation	4	4
Air Embolism	4	4
Ischemia	4	4
Brain Injury	4	4
Hematuria	4	4
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 Cardiovascular Us Sales, Llc	II	Dec-12-2019
5	Maquet Medical Systems USA	II	Feb-02-2024
6	OriGen Biomedical, Inc.	II	Oct-30-2020
7	QURA S.R.L.	II	Aug-12-2021
8	Thoratec Switzerland GMBH	I	Oct-30-2019