TPLC - Total Product Life Cycle

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Device	control, pump speed, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass pump speed control.
Product Code	DWA
Regulation Number	870.4380
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT (FORMERLY THORATEC CORPORATION)
	SUBSTANTIALLY EQUIVALENT	1
APMTD, INC.
	SUBSTANTIALLY EQUIVALENT	2
INSPIRA TECHNOLOGIES OXY B.H.N. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
THORATEC CORPORATION (NOW PART OF ABBOTT)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	320	321
Battery Problem	282	282
Power Problem	198	198
Device Alarm System	194	195
Pumping Stopped	169	171
Infusion or Flow Problem	160	162
Electrical /Electronic Property Problem	127	127
Unexpected Shutdown	102	103
Pumping Problem	97	97
Display or Visual Feedback Problem	90	90
Noise, Audible	83	85
Mechanical Problem	77	78
Communication or Transmission Problem	64	64
Decreased Pump Speed	55	55
Overheating of Device	46	46
No Display/Image	44	45
Obstruction of Flow	38	38
No Apparent Adverse Event	32	33
Improper or Incorrect Procedure or Method	28	30
Smoking	28	28
Failure to Power Up	26	26
Appropriate Term/Code Not Available	22	23
No Flow	22	24
Material Deformation	20	20
Electrical Power Problem	18	18
Insufficient Flow or Under Infusion	16	17
Use of Device Problem	13	13
Vibration	13	13
Partial Blockage	13	13
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Excessive Heating	11	11
Detachment of Device or Device Component	11	11
Nonstandard Device	10	10
Device Difficult to Setup or Prepare	10	10
Connection Problem	9	9
Failure of Device to Self-Test	9	9
Failure to Pump	9	9
Break	9	9
No Audible Alarm	9	9
Difficult to Open or Close	8	10
Failure to Charge	7	7
Unable to Obtain Readings	7	7
Failure to Interrogate	7	7
Mechanical Jam	7	7
Increased Pump Speed	7	7
Alarm Not Visible	7	7
Disconnection	6	6
Loss of Power	6	6
Complete Loss of Power	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1480	1494
No Consequences Or Impact To Patient	195	195
No Known Impact Or Consequence To Patient	151	151
No Patient Involvement	139	139
Insufficient Information	31	33
Low Oxygen Saturation	17	17
Cardiac Arrest	14	14
Death	12	12
Low Blood Pressure/ Hypotension	10	11
No Information	8	8
Thrombus	6	6
Hemorrhage/Bleeding	4	4
Hypoxia	4	4
Stroke/CVA	3	3
Respiratory Insufficiency	3	3
Hemolysis	3	3
No Code Available	3	4
Loss of consciousness	3	3
Thrombosis/Thrombus	3	4
Dyspnea	3	4
Asystole	2	2
Bradycardia	2	2
Infarction, Cerebral	2	2
Cardiogenic Shock	1	1
Cardiopulmonary Arrest	1	1
Chest Pain	1	1
Respiratory Acidosis	1	1
Shock	1	1
Anxiety	1	1
Cough	1	1
Unspecified Tissue Injury	1	1
Multiple Organ Failure	1	1
Cardiovascular Insufficiency	1	1
Blood Loss	1	1
Ischemia	1	1
Exsanguination	1	2
Complaint, Ill-Defined	1	1
Bacterial Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Syncope/Fainting	1	1
Hypovolemia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardiac Assist, Inc	I	Jan-19-2023
2	Cardiac Assist, Inc	I	Sep-23-2022
3	LivaNova Deutschland GmbH	III	Mar-15-2022
4	LivaNova Deutschland GmbH	II	Jul-08-2020
5	Medtronic Perfusion Systems	I	Mar-26-2021