TPLC - Total Product Life Cycle

show TPLC since

Device	control, pump speed, cardiopulmonary bypass
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	1
APMTD, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSPIRA TECHNOLOGIES OXY B.H.N LTD.
	SUBSTANTIALLY EQUIVALENT	1
LEVITRONIX LLC.
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1
SORIN GROUP DEUTSCHLAND GMBH
	SUBSTANTIALLY EQUIVALENT	3
SPECTRUM MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
THORATEC CORP
	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	244	244
Pumping Stopped	214	214
Battery Problem	191	191
Power Problem	169	169
Device Alarm System	153	153
Infusion or Flow Problem	147	147
Mechanical Problem	127	127
No Display/Image	116	116
Pumping Problem	90	90
Noise, Audible	89	89
Other (for use when an appropriate device code cannot be identified)	87	87
Electrical /Electronic Property Problem	72	72
Display or Visual Feedback Problem	70	70
Unexpected Shutdown	70	70
Decreased Pump Speed	66	66
Device Displays Incorrect Message	65	65
Overheating of Device	57	57
Communication or Transmission Problem	57	57
No Flow	38	38
Device Operates Differently Than Expected	37	37
Device Stops Intermittently	35	35
Smoking	31	31
Obstruction of Flow	30	30
Appropriate Term/Code Not Available	27	27
Failure to Power Up	26	26
Incorrect, Inadequate or Imprecise Result or Readings	24	24
Device Operational Issue	24	24
No Apparent Adverse Event	24	24
Break	24	24
Insufficient Flow or Under Infusion	21	21
Electrical Power Problem	20	20
Loss of Power	17	17
Material Deformation	16	16
Vibration	16	16
Adverse Event Without Identified Device or Use Problem	16	16
Improper or Incorrect Procedure or Method	16	16
Partial Blockage	13	13
Inaccurate Flow Rate	13	13
Detachment of Device or Device Component	10	10
Use of Device Problem	10	10
Temperature Problem	10	10
Device Inoperable	10	10
Connection Problem	9	9
Excessive Heating	9	9
Unable to Obtain Readings	9	9
Mechanical Jam	8	8
Loose or Intermittent Connection	8	8
Difficult to Open or Close	8	8
No Audible Alarm	8	8
Improper Flow or Infusion	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1041	1041
No Consequences Or Impact To Patient	463	463
No Patient Involvement	274	274
No Known Impact Or Consequence To Patient	272	272
No Patient involvement	43	43
Low Blood Pressure/ Hypotension	28	28
Insufficient Information	27	27
Low Oxygen Saturation	20	20
Death	20	20
No Information	18	18
Complaint, Ill-Defined	17	17
Cardiac Arrest	17	17
Thrombus	9	9
Hemolysis	6	6
No Code Available	6	6
Dizziness	6	6
Loss of consciousness	5	5
Hemorrhage/Bleeding	5	5
Hypoxia	5	5
Bradycardia	5	5
Infarction, Cerebral	4	4
Not Applicable	4	4
Blood Loss	4	4
Anxiety	4	4
Patient Problem/Medical Problem	3	3
Stroke/CVA	3	3
Respiratory Insufficiency	3	3
Bacterial Infection	3	3
Neurological Deficit/Dysfunction	3	3
Dyspnea	3	3
Respiratory Failure	2	2
Ventilator Dependent	2	2
Asystole	2	2
Cardiogenic Shock	2	2
Multiple Organ Failure	2	2
Heart Failure	2	2
Seizures	2	2
Air Embolism	2	2
Thrombosis/Thrombus	1	1
Chest Pain	1	1
Thrombosis	1	1
Foreign Body In Patient	1	1
Cardiopulmonary Arrest	1	1
Coma	1	1
Ventricular Fibrillation	1	1
Rash	1	1
Pulmonary Edema	1	1
Shock	1	1
Cough	1	1
Unspecified Tissue Injury	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 Cardiovascular Revascularization & Surgical Therap	II	Jun-30-2010
6	Medtronic Perfusion Systems	I	Mar-26-2021
7	Sorin Group Deutschland GmbH	II	Jan-19-2018
8	Sorin Group Deutschland GmbH	II	Jan-28-2014
9	Sorin Group Deutschland GmbH	II	Mar-29-2012
10	Sorin Group USA, Inc.	II	Oct-29-2012