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
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	3
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	516	517
Insufficient Information	222	224
Pumping Stopped	171	171
Adverse Event Without Identified Device or Use Problem	133	140
Infusion or Flow Problem	107	109
Mechanical Problem	93	94
Noise, Audible	91	91
Unexpected Shutdown	72	72
Battery Problem	71	72
Overheating of Device	51	51
Inaccurate Flow Rate	34	34
Fluid/Blood Leak	32	34
Communication or Transmission Problem	28	28
Device Difficult to Setup or Prepare	23	23
No Apparent Adverse Event	20	21
Pumping Problem	19	20
Crack	19	20
Increased Pump Speed	16	16
Obstruction of Flow	15	15
Break	15	16
Decreased Pump Speed	13	13
Insufficient Flow or Under Infusion	13	13
Material Deformation	12	13
Failure to Power Up	11	12
Improper Flow or Infusion	11	11
Detachment of Device or Device Component	10	10
No Flow	8	8
Premature Discharge of Battery	8	8
Material Puncture/Hole	8	8
Device Displays Incorrect Message	7	7
No Display/Image	7	7
Loose or Intermittent Connection	7	7
Leak/Splash	7	7
Failure to Pump	6	6
Electrical Power Problem	6	6
Display or Visual Feedback Problem	6	6
Unexpected Therapeutic Results	6	6
Product Quality Problem	6	6
Excessive Heating	6	6
Fracture	5	5
Use of Device Problem	5	5
Image Display Error/Artifact	4	4
Air/Gas in Device	4	5
No Visual Prompts/Feedback	4	4
Disconnection	4	4
Gas/Air Leak	4	4
Partial Blockage	3	3
Backflow	3	3
Circuit Failure	3	3
Contamination	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1343	1353
Insufficient Information	114	114
Hemorrhage/Bleeding	65	69
Thrombosis/Thrombus	44	45
Hemolysis	31	32
Cardiac Arrest	30	30
Heart Failure/Congestive Heart Failure	24	28
Bacterial Infection	19	19
Low Oxygen Saturation	17	17
Ischemia Stroke	15	15
Arrhythmia	15	17
Renal Failure	15	15
Thromboembolism	13	14
No Consequences Or Impact To Patient	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Multiple Organ Failure	12	12
Low Blood Pressure/ Hypotension	11	12
Respiratory Failure	10	10
Atrial Fibrillation	10	11
Sepsis	10	10
Tachycardia	10	11
Unspecified Infection	9	9
Stroke/CVA	9	10
No Patient Involvement	8	8
Renal Impairment	8	9
Hypoxia	7	7
Fungal Infection	7	7
Hemorrhagic Stroke	7	7
Convulsion/Seizure	6	6
No Known Impact Or Consequence To Patient	6	6
High Blood Pressure/ Hypertension	6	6
Air Embolism	6	6
Cardiogenic Shock	6	6
Hematoma	5	5
Gastrointestinal Hemorrhage	5	5
Anemia	5	5
Septic Shock	5	5
Intracranial Hemorrhage	5	6
Respiratory Insufficiency	4	4
Lactate Dehydrogenase Increased	4	4
Ventricular Fibrillation	4	4
Respiratory Arrest	3	3
Hematuria	3	3
Ischemia	3	3
Encephalopathy	3	3
Dyspnea	3	3
Liver Failure	3	3
Thrombocytopenia	2	2
Cough	2	2
Shock	2	2