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
APMTD, INC.
	SUBSTANTIALLY EQUIVALENT	2
INSPIRA TECHNOLOGIES OXY B.H.N. , LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	310	311
Battery Problem	289	289
Power Problem	194	194
Device Alarm System	191	191
Electrical /Electronic Property Problem	129	129
Infusion or Flow Problem	124	126
Pumping Stopped	105	107
Unexpected Shutdown	93	94
Display or Visual Feedback Problem	77	77
Pumping Problem	65	65
Mechanical Problem	55	56
Noise, Audible	49	50
No Apparent Adverse Event	42	43
Obstruction of Flow	36	36
Improper or Incorrect Procedure or Method	27	29
Failure to Power Up	27	27
Smoking	26	26
Communication or Transmission Problem	24	24
Material Deformation	19	19
No Display/Image	18	19
Overheating of Device	18	18
Decreased Pump Speed	18	18
Use of Device Problem	14	14
No Flow	12	14
Electrical Power Problem	12	12
Failure to Interrogate	12	12
Device Difficult to Setup or Prepare	12	12
Failure to Pump	11	11
Difficult to Open or Close	9	11
No Audible Alarm	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Insufficient Flow or Under Infusion	8	9
Failure of Device to Self-Test	7	7
Nonstandard Device	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Failure to Charge	7	7
Alarm Not Visible	6	6
Increase in Pressure	6	6
Complete Loss of Power	5	5
Excessive Heating	5	5
Data Problem	5	5
Intermittent Communication Failure	4	4
Unable to Obtain Readings	4	4
Increased Pump Speed	4	4
Connection Problem	4	4
Display Difficult to Read	4	4
Temperature Problem	3	5
Sparking	3	3
Inaccurate Flow Rate	3	3
Calibration Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1566	1580
Insufficient Information	31	33
Low Oxygen Saturation	14	14
Cardiac Arrest	8	8
Low Blood Pressure/ Hypotension	7	7
Hypoxia	4	4
No Patient Involvement	3	3
Dyspnea	3	4
No Consequences Or Impact To Patient	3	3
Respiratory Insufficiency	3	3
Stroke/CVA	2	2
Convulsion/Seizure	2	2
Hemorrhage/Bleeding	2	2
Loss of consciousness	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Syncope/Fainting	1	1
Hemolysis	1	1
Ischemia	1	1
Exsanguination	1	2
Multiple Organ Failure	1	1
Respiratory Acidosis	1	1
Thrombosis/Thrombus	1	2
Cardiogenic Shock	1	1
Chest Pain	1	1
Asystole	1	1
Bradycardia	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	Medtronic Perfusion Systems	I	Mar-26-2021