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	376	376
Insufficient Information	240	240
Adverse Event Without Identified Device or Use Problem	190	190
Pumping Stopped	189	189
Noise, Audible	180	180
Infusion or Flow Problem	126	126
Device Displays Incorrect Message	119	119
Mechanical Problem	118	118
Overheating of Device	90	90
Unexpected Shutdown	80	80
Battery Problem	79	79
Communication or Transmission Problem	48	48
Inaccurate Flow Rate	39	39
Pumping Problem	37	37
No Flow	26	26
Decreased Pump Speed	25	25
Fluid/Blood Leak	23	23
Device Difficult to Setup or Prepare	23	23
Insufficient Flow or Under Infusion	22	22
Increased Pump Speed	20	20
No Apparent Adverse Event	18	18
No Display/Image	17	17
Excessive Heating	16	16
Material Twisted/Bent	16	16
Break	16	16
Disconnection	15	15
Display or Visual Feedback Problem	14	14
Electrical Power Problem	12	12
Obstruction of Flow	12	12
Use of Device Problem	11	11
Crack	11	11
Leak/Splash	11	11
Power Problem	10	10
Detachment of Device or Device Component	10	10
Failure to Pump	10	10
Failure to Power Up	9	9
Premature Discharge of Battery	8	8
Product Quality Problem	8	8
Loose or Intermittent Connection	7	7
Vibration	7	7
Connection Problem	7	7
Improper Flow or Infusion	7	7
Loss of Power	6	6
Unexpected Therapeutic Results	6	6
Material Deformation	6	6
Fracture	6	6
Fitting Problem	6	6
Device Alarm System	5	5
Temperature Problem	5	5
Charging Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1082	1082
No Consequences Or Impact To Patient	281	281
No Patient Involvement	205	205
No Known Impact Or Consequence To Patient	175	175
Insufficient Information	103	103
Hemorrhage/Bleeding	65	65
Thrombosis/Thrombus	45	45
Death	42	42
Hemolysis	35	35
Cardiac Arrest	32	32
Heart Failure/Congestive Heart Failure	28	28
No Information	22	22
Thrombus	21	21
Low Oxygen Saturation	20	20
Bacterial Infection	19	19
Arrhythmia	18	18
Renal Failure	17	17
Multiple Organ Failure	14	14
Thromboembolism	14	14
Blood Loss	13	13
Ischemia Stroke	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Tachycardia	11	11
Hypoxia	11	11
Stroke/CVA	11	11
Unspecified Infection	11	11
Respiratory Failure	11	11
Cardiogenic Shock	10	10
Low Blood Pressure/ Hypotension	10	10
Atrial Fibrillation	10	10
Sepsis	9	9
Renal Impairment	8	8
Fungal Infection	7	7
Hematoma	7	7
Intracranial Hemorrhage	6	6
Anemia	6	6
Gastrointestinal Hemorrhage	5	5
Hemorrhagic Stroke	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
Brain Injury	4	4
Air Embolism	4	4
Ischemia	4	4
Hematuria	4	4
Shock	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