TPLC - Total Product Life Cycle

show TPLC since

Device	set, tubing, blood, with and without anti-regurgitation valve
Product Code	FJK
Regulation Number	876.5820
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SANXIN MEDTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OUTSET MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	735	735
Leak/Splash	336	336
Air/Gas in Device	292	292
Detachment of Device or Device Component	194	194
Material Puncture/Hole	176	176
Adverse Event Without Identified Device or Use Problem	60	60
Crack	46	46
Disconnection	37	37
Contamination /Decontamination Problem	30	30
Loose or Intermittent Connection	27	27
Obstruction of Flow	21	21
Break	18	18
Material Deformation	16	16
Degraded	10	10
Material Split, Cut or Torn	9	9
Separation Problem	9	9
Defective Component	6	6
Inadequate Filtration Process	5	5
Device Contamination with Chemical or Other Material	5	5
Material Separation	5	5
Improper or Incorrect Procedure or Method	5	5
Gas/Air Leak	5	5
Connection Problem	5	5
No Fail-Safe Mechanism	4	4
Component Missing	4	4
Pressure Problem	3	3
Output Problem	3	3
Device Alarm System	3	3
Improper Flow or Infusion	3	3
Protective Measures Problem	2	2
Defective Device	2	2
No Flow	2	2
Loss of Power	2	2
Failure of Device to Self-Test	2	2
Material Rupture	2	2
Material Twisted/Bent	2	2
No Audible Alarm	2	2
Tear, Rip or Hole in Device Packaging	2	2
Device Handling Problem	1	1
Delivered as Unsterile Product	1	1
Coagulation in Device or Device Ingredient	1	1
Nonstandard Device	1	1
Inflation Problem	1	1
Unintended Ejection	1	1
Use of Device Problem	1	1
Display or Visual Feedback Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Contamination	1	1
Failure to Deliver	1	1
Filtration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	939	939
Hemorrhage/Bleeding	392	392
No Known Impact Or Consequence To Patient	266	266
No Consequences Or Impact To Patient	42	42
Insufficient Information	34	34
Low Blood Pressure/ Hypotension	30	30
Blood Loss	29	29
Cardiac Arrest	20	20
Hemolysis	18	18
Loss of consciousness	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Dizziness	8	8
Exsanguination	8	8
Anemia	8	8
Death	6	6
Hypersensitivity/Allergic reaction	6	6
Dyspnea	6	6
No Patient Involvement	5	5
Hypovolemia	4	4
High Blood Pressure/ Hypertension	4	4
Syncope/Fainting	4	4
Low Oxygen Saturation	4	4
Itching Sensation	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Chest Pain	4	4
Syncope	3	3
Nausea	3	3
No Code Available	3	3
Bradycardia	3	3
Cardiopulmonary Arrest	3	3
Hypervolemia	2	2
Decreased Respiratory Rate	2	2
Convulsion/Seizure	2	2
Hypoxia	2	2
Anxiety	2	2
Congestive Heart Failure	2	2
Vomiting	2	2
Loss Of Pulse	2	2
Confusion/ Disorientation	2	2
Chemical Exposure	2	2
Malaise	2	2
Air Embolism	2	2
Abdominal Pain	2	2
Thrombosis/Thrombus	1	1
Foreign Body In Patient	1	1
Convulsion, Tonic	1	1
Weakness	1	1
Rash	1	1
Jaundice	1	1
Angina	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B Braun Medical Inc	II	Sep-19-2024
2	Baxter Healthcare Corporation	II	May-26-2021
3	Baxter Healthcare Corporation	II	Feb-16-2021
4	Baxter Healthcare Corporation	II	Jun-01-2020
5	ICU Medical, Inc.	II	Dec-23-2020