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 Device Problem Information	348	349
Battery Problem	301	301
Power Problem	205	205
Device Alarm System	199	199
Infusion or Flow Problem	149	151
Electrical /Electronic Property Problem	144	144
Pumping Stopped	125	127
Unexpected Shutdown	100	101
Display or Visual Feedback Problem	89	89
Pumping Problem	88	88
Mechanical Problem	68	69
Noise, Audible	54	55
No Apparent Adverse Event	46	47
Obstruction of Flow	37	37
Failure to Power Up	32	32
Improper or Incorrect Procedure or Method	28	29
Communication or Transmission Problem	27	27
Smoking	26	26
Overheating of Device	25	25
No Display/Image	24	25
Decreased Pump Speed	23	23
Material Deformation	21	21
Electrical Power Problem	15	15
Use of Device Problem	14	14
Adverse Event Without Identified Device or Use Problem	12	12
Device Difficult to Setup or Prepare	12	12
Failure to Interrogate	12	12
Failure to Pump	12	12
Incorrect, Inadequate or Imprecise Result or Readings	11	11
No Audible Alarm	9	9
Failure of Device to Self-Test	9	9
No Flow	9	11
Alarm Not Visible	9	9
Difficult to Open or Close	9	11
Insufficient Flow or Under Infusion	8	9
Excessive Heating	8	8
Complete Loss of Power	8	8
Failure to Charge	7	7
Nonstandard Device	7	7
Increase in Pressure	6	6
Increased Pump Speed	6	6
Data Problem	5	5
Unable to Obtain Readings	4	4
Appropriate Device Problem Term/Code Not Available	4	4
Calibration Problem	4	4
Display Difficult to Read	4	4
Intermittent Communication Failure	4	4
Connection Problem	4	4
Loose or Intermittent Connection	3	3
Sparking	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1665	1679
No Consequences Or Impact To Patient	83	83
No Patient Involvement	38	38
Insufficient Information	33	35
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
Hemorrhage/Blood Loss/Bleeding	5	5
Hypoxia	4	4
No Information	4	4
Hemodynamic instability	3	3
Thrombus	3	3
Dyspnea	3	4
Hemolysis	3	3
Respiratory Insufficiency	3	3
Convulsion/Seizure	2	2
Reduced Blood Flow	2	2
Bradycardia	2	2
Loss of consciousness	2	2
Multiple Organ Dysfunction Syndrome	2	2
Asystole	2	2
Stroke/CVA	2	2
Cardiogenic Shock	1	1
Cough	1	1
Cardiovascular Dysfunction/Insufficiency	1	1
Thrombosis/Thrombus	1	2
Cardiopulmonary Arrest	1	1
Ischemia	1	1
Hypovolemia	1	1
No Code Available	1	1
Blood Loss	1	1
Shock	1	1
Syncope/Fainting	1	1
Bacteremia	1	1
Chest Pain	1	1
Unspecified Tissue Injury	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Bacterial Infection	1	1
Exsanguination	1	2
Respiratory Acidosis	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