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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	305	306
Battery Problem	275	275
Power Problem	187	187
Device Alarm System	182	183
Infusion or Flow Problem	138	140
Electrical /Electronic Property Problem	124	124
Pumping Stopped	117	119
Unexpected Shutdown	86	87
Pumping Problem	86	86
Display or Visual Feedback Problem	80	80
Mechanical Problem	67	68
Noise, Audible	50	52
Obstruction of Flow	36	36
No Apparent Adverse Event	32	33
Improper or Incorrect Procedure or Method	28	30
Communication or Transmission Problem	27	27
Failure to Power Up	25	25
Smoking	25	25
No Display/Image	24	25
Decreased Pump Speed	22	22
Material Deformation	20	20
Overheating of Device	19	19
Electrical Power Problem	15	15
No Flow	14	16
Use of Device Problem	11	11
Device Difficult to Setup or Prepare	9	9
Excessive Heating	9	9
No Audible Alarm	9	9
Adverse Event Without Identified Device or Use Problem	9	9
Incorrect, Inadequate or Imprecise Result or Readings	8	8
Insufficient Flow or Under Infusion	8	9
Failure to Pump	8	8
Failure of Device to Self-Test	8	8
Difficult to Open or Close	8	10
Failure to Interrogate	7	7
Alarm Not Visible	7	7
Nonstandard Device	7	7
Failure to Charge	7	7
Increased Pump Speed	6	6
Increase in Pressure	6	6
Complete Loss of Power	6	6
Data Problem	5	5
Appropriate Term/Code Not Available	5	6
Unable to Obtain Readings	4	4
Intermittent Communication Failure	4	4
Display Difficult to Read	4	4
Detachment of Device or Device Component	4	4
Disconnection	3	3
Temperature Problem	3	5
Inaccurate Flow Rate	3	3

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	83	83
No Patient Involvement	38	38
Insufficient Information	31	33
Low Oxygen Saturation	17	17
Cardiac Arrest	11	11
Low Blood Pressure/ Hypotension	9	10
Death	6	6
No Known Impact Or Consequence To Patient	6	6
No Information	4	4
Hypoxia	4	4
Hemorrhage/Bleeding	4	4
Hemolysis	3	3
Thrombosis/Thrombus	3	4
Dyspnea	3	4
Respiratory Insufficiency	3	3
Thrombus	3	3
Stroke/CVA	2	2
Bradycardia	2	2
Asystole	2	2
Loss of consciousness	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Syncope/Fainting	1	1
No Code Available	1	1
Ischemia	1	1
Exsanguination	1	2
Multiple Organ Failure	1	1
Blood Loss	1	1
Respiratory Acidosis	1	1
Cardiogenic Shock	1	1
Chest Pain	1	1
Cardiopulmonary Arrest	1	1
Unspecified Tissue Injury	1	1
Shock	1	1
Cough	1	1
Cardiovascular Insufficiency	1	1
Bacterial Infection	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