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	2
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
Noise, Audible	263	263
Insufficient Information	241	241
Pumping Stopped	211	211
Adverse Event Without Identified Device or Use Problem	201	201
Mechanical Problem	159	159
Infusion or Flow Problem	142	142
Device Displays Incorrect Message	129	129
Overheating of Device	107	107
Battery Problem	94	94
Unexpected Shutdown	80	80
Communication or Transmission Problem	50	50
Pumping Problem	42	42
Inaccurate Flow Rate	39	39
Decreased Pump Speed	30	30
No Display/Image	29	29
No Flow	28	28
Fluid/Blood Leak	27	27
Break	23	23
Insufficient Flow or Under Infusion	23	23
Device Difficult to Setup or Prepare	23	23
Leak/Splash	20	20
Increased Pump Speed	20	20
Crack	19	19
No Apparent Adverse Event	19	19
Material Twisted/Bent	18	18
Disconnection	16	16
Excessive Heating	16	16
Display or Visual Feedback Problem	14	14
Power Problem	14	14
Electrical Power Problem	13	13
Obstruction of Flow	12	12
Device Stops Intermittently	12	12
Use of Device Problem	11	11
Vibration	11	11
Failure to Pump	11	11
Connection Problem	10	10
Failure to Power Up	10	10
Charging Problem	10	10
Detachment of Device or Device Component	10	10
Improper Flow or Infusion	9	9
Loss of Power	8	8
Premature Discharge of Battery	8	8
Product Quality Problem	8	8
Fracture	7	7
Device Operates Differently Than Expected	7	7
Loose or Intermittent Connection	7	7
Temperature Problem	6	6
Unexpected Therapeutic Results	6	6
Fitting Problem	6	6

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	327	327
No Patient Involvement	317	317
No Known Impact Or Consequence To Patient	255	255
Insufficient Information	103	103
Hemorrhage/Bleeding	65	65
Death	57	57
Thrombosis/Thrombus	45	45
Cardiac Arrest	39	39
Hemolysis	36	36
Thrombus	30	30
Heart Failure/Congestive Heart Failure	28	28
No Information	25	25
Blood Loss	21	21
Low Oxygen Saturation	20	20
Bacterial Infection	19	19
Arrhythmia	18	18
Renal Failure	18	18
Multiple Organ Failure	16	16
Thromboembolism	15	15
Low Blood Pressure/ Hypotension	15	15
Stroke/CVA	14	14
Ischemia Stroke	13	13
Unspecified Infection	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Hypoxia	11	11
Tachycardia	11	11
Atrial Fibrillation	11	11
Respiratory Failure	11	11
Cardiogenic Shock	11	11
Sepsis	9	9
Renal Impairment	8	8
Complaint, Ill-Defined	7	7
Fungal Infection	7	7
Intracranial Hemorrhage	7	7
Thrombosis	7	7
Hematoma	7	7
Anemia	6	6
Ischemia	6	6
Air Embolism	5	5
Gastrointestinal Hemorrhage	5	5
Hemorrhagic Stroke	5	5
Injury	5	5
Ventricular Fibrillation	4	4
Dyspnea	4	4
Coagulation Disorder	4	4
Lactate Dehydrogenase Increased	4	4
Hematuria	4	4
Bradycardia	4	4
Reaction	4	4

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	Terumo Cardiovascular Systems Corporation	II	Feb-22-2017
9	Thoratec Switzerland GMBH	I	Oct-30-2019
10	Thoratec Switzerland GMBH	II	Oct-12-2018