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	536	537
Insufficient Information	239	241
Pumping Stopped	188	188
Adverse Event Without Identified Device or Use Problem	135	142
Infusion or Flow Problem	108	110
Mechanical Problem	101	102
Noise, Audible	94	94
Battery Problem	78	79
Unexpected Shutdown	72	72
Overheating of Device	52	52
Inaccurate Flow Rate	35	35
Fluid/Blood Leak	32	34
Communication or Transmission Problem	29	29
Device Difficult to Setup or Prepare	26	26
No Apparent Adverse Event	23	24
Pumping Problem	20	21
Crack	19	20
Obstruction of Flow	17	17
Increased Pump Speed	16	16
Break	16	17
Material Deformation	14	15
Decreased Pump Speed	13	13
Insufficient Flow or Under Infusion	13	13
Failure to Power Up	13	14
Detachment of Device or Device Component	11	11
Improper Flow or Infusion	11	11
Premature Discharge of Battery	9	9
Material Puncture/Hole	8	8
No Display/Image	8	8
No Flow	8	8
Loose or Intermittent Connection	7	7
Device Displays Incorrect Message	7	7
Leak/Splash	7	7
Unexpected Therapeutic Results	6	6
Electrical Power Problem	6	6
Excessive Heating	6	6
Display or Visual Feedback Problem	6	6
Product Quality Problem	6	6
Failure to Pump	6	6
Fracture	5	5
Use of Device Problem	5	5
No Visual Prompts/Feedback	4	4
Image Display Error/Artifact	4	4
Failure to Run on Battery	4	4
Gas/Air Leak	4	4
Air/Gas in Device	4	5
Disconnection	4	4
Backflow	4	4
Decoupling	3	3
Partial Blockage	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1418	1428
Insufficient Information	118	118
Hemorrhage/Bleeding	66	70
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
Renal Failure	15	15
Arrhythmia	15	17
Ischemia Stroke	15	15
No Consequences Or Impact To Patient	13	13
Thromboembolism	13	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Multiple Organ Failure	12	12
Low Blood Pressure/ Hypotension	11	12
Tachycardia	10	11
Sepsis	10	10
Atrial Fibrillation	10	11
Respiratory Failure	10	10
Unspecified Infection	9	9
Stroke/CVA	9	10
Renal Impairment	8	9
No Patient Involvement	8	8
Hypoxia	7	7
Fungal Infection	7	7
Hemorrhagic Stroke	7	7
Cardiogenic Shock	6	6
No Known Impact Or Consequence To Patient	6	6
Air Embolism	6	6
High Blood Pressure/ Hypertension	6	6
Hematoma	5	5
Septic Shock	5	5
Anemia	5	5
Intracranial Hemorrhage	5	6
Gastrointestinal Hemorrhage	5	5
Lactate Dehydrogenase Increased	4	4
Ventricular Fibrillation	4	4
Respiratory Insufficiency	4	4
Encephalopathy	3	3
Liver Failure	3	3
Dyspnea	3	3
Respiratory Arrest	3	3
Hematuria	3	3
Ischemia	3	3
Coagulation Disorder	3	3
Unspecified Gastrointestinal Problem	2	2
Aspiration Pneumonitis	2	2
Epistaxis	2	2