TPLC - Total Product Life Cycle

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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
BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DIMESOL, INC.
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
GAMBRO RENAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
HOME DIALYSIS PLUS
	SUBSTANTIALLY EQUIVALENT	1
JIANGXI SANXIN MEDTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIPRO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NXSTAGE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
OUTSET MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
OXYLESS LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	975	975
Leak/Splash	396	396
Air/Gas in Device	292	292
Adverse Event Without Identified Device or Use Problem	210	210
Detachment of Device or Device Component	197	197
Material Puncture/Hole	179	179
Disconnection	79	79
Crack	61	61
Insufficient Information	49	49
Loose or Intermittent Connection	46	46
Contamination /Decontamination Problem	30	30
Connection Problem	27	27
Air Leak	24	24
Obstruction of Flow	23	23
Break	20	20
Occlusion Within Device	17	17
Material Separation	16	16
Detachment Of Device Component	16	16
Material Deformation	16	16
Device Dislodged or Dislocated	15	15
Device Operates Differently Than Expected	12	12
Misconnection	11	11
Kinked	11	11
Degraded	10	10
Defective Component	9	9
Material Split, Cut or Torn	9	9
Separation Problem	9	9
Hole In Material	8	8
No Fail-Safe Mechanism	8	8
Device Displays Incorrect Message	7	7
Device Contamination with Chemical or Other Material	6	6
Material Rupture	6	6
Inadequate Filtration Process	6	6
Pressure Problem	6	6
Improper Flow or Infusion	6	6
Material Perforation	5	5
Improper or Incorrect Procedure or Method	5	5
Failure To Adhere Or Bond	5	5
Migration or Expulsion of Device	5	5
Gas/Air Leak	5	5
Device Operational Issue	4	4
Component Missing	4	4
Increase in Pressure	4	4
Coagulation in Device or Device Ingredient	4	4
Device Alarm System	4	4
Use of Device Problem	3	3
Device Handling Problem	3	3
Output Problem	3	3
Split	3	3
Torn Material	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	939	939
No Known Impact Or Consequence To Patient	513	513
Hemorrhage/Bleeding	396	396
Blood Loss	160	160
Death	82	82
No Consequences Or Impact To Patient	79	79
Low Blood Pressure/ Hypotension	63	63
Cardiac Arrest	56	56
Hemolysis	55	55
Loss of consciousness	41	41
Cardiopulmonary Arrest	35	35
Insufficient Information	34	34
Dyspnea	22	22
Chest Pain	18	18
Exsanguination	18	18
Anemia	15	15
Hypovolemia	13	13
Syncope	13	13
Nausea	11	11
Abdominal Pain	11	11
Hypersensitivity/Allergic reaction	10	10
Dizziness	9	9
High Blood Pressure/ Hypertension	9	9
Bradycardia	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Vomiting	8	8
No Code Available	8	8
No Patient Involvement	8	8
Loss Of Pulse	7	7
Air Embolism	6	6
Myocardial Infarction	6	6
Seizures	5	5
Diaphoresis	5	5
Malaise	5	5
Hypoxia	5	5
Confusion/ Disorientation	5	5
Itching Sensation	5	5
Hypervolemia	4	4
Pain	4	4
Peritonitis	4	4
Syncope/Fainting	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Tachycardia	4	4
Pulmonary Embolism	4	4
Headache	4	4
Low Oxygen Saturation	4	4
Reaction	3	3
Anxiety	3	3
Sudden Cardiac Death	3	3
Unspecified Infection	3	3

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	Fresenius Medical Care Holdings, Inc.	I	Jan-10-2011
6	Gambro Renal Products, Incorporated	II	Apr-11-2014
7	ICU Medical, Inc.	II	Dec-23-2020
8	Nipro Medical Corporation	II	May-15-2018
9	Nipro Medical Corporation	II	Jan-08-2016