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	347	348
Battery Problem	296	296
Power Problem	206	206
Device Alarm System	201	202
Pumping Stopped	171	173
Infusion or Flow Problem	164	166
Electrical /Electronic Property Problem	136	136
Unexpected Shutdown	113	114
Pumping Problem	98	98
Display or Visual Feedback Problem	96	96
Noise, Audible	86	88
Mechanical Problem	78	79
Communication or Transmission Problem	64	64
Decreased Pump Speed	55	55
Overheating of Device	47	47
No Display/Image	44	45
No Apparent Adverse Event	41	42
Obstruction of Flow	39	39
Smoking	29	29
Failure to Power Up	29	29
Improper or Incorrect Procedure or Method	28	30
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	16	16
Vibration	14	14
Incorrect, Inadequate or Imprecise Result or Readings	14	14
Partial Blockage	13	13
Device Difficult to Setup or Prepare	13	13
Failure to Interrogate	12	12
Excessive Heating	11	11
Detachment of Device or Device Component	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Connection Problem	10	10
Nonstandard Device	10	10
Failure of Device to Self-Test	9	9
Break	9	9
Failure to Pump	9	9
No Audible Alarm	9	9
Complete Loss of Power	8	8
Difficult to Open or Close	8	10
Mechanical Jam	7	7
Unable to Obtain Readings	7	7
Increased Pump Speed	7	7
Alarm Not Visible	7	7
Failure to Charge	7	7
Disconnection	6	6
Loss of Power	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1571	1585
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
No Code Available	3	4
Hemolysis	3	3
Respiratory Insufficiency	3	3
Loss of consciousness	3	3
Dyspnea	3	4
Infarction, Cerebral	2	2
Convulsion/Seizure	2	2
Bradycardia	2	2
Asystole	2	2
Hypovolemia	1	1
Bacterial Infection	1	1
Cardiovascular Insufficiency	1	1
Cough	1	1
Shock	1	1
Unspecified Tissue Injury	1	1
Anxiety	1	1
Cardiopulmonary Arrest	1	1
Chest Pain	1	1
Cardiogenic Shock	1	1
Thrombosis/Thrombus	1	2
Respiratory Acidosis	1	1
Blood Loss	1	1
Multiple Organ Failure	1	1
Exsanguination	1	2
Ischemia	1	1
Complaint, Ill-Defined	1	1
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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