TPLC - Total Product Life Cycle

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Device	extracorporeal system for long-term respiratory / cardiopulmonary failure
Regulation Description	Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Definition	Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Product Code	QJZ
Regulation Number	870.4100
Device Class	2

Premarket Reviews
Manufacturer	Decision
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	183	183
Insufficient Device Problem Information	95	95
Communication or Transmission Problem	90	90
Output Problem	74	74
Incorrect, Inadequate or Imprecise Result or Readings	71	71
Mechanical Problem	66	66
Leak/Splash	64	64
Adverse Event Without Identified Device or Use Problem	39	39
Protective Measures Problem	13	13
Device Alarm System	12	12
Obstruction of Flow	12	12
Infusion or Flow Problem	10	10
Material Integrity Problem	8	8
Noise, Audible	7	7
Electrical /Electronic Property Problem	7	7
Material Separation	6	6
Improper Flow or Infusion	6	6
Air/Gas in Device	5	5
Crack	5	5
Defective Component	4	4
Display or Visual Feedback Problem	4	4
No Flow	4	4
Contamination	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Insufficient Flow or Under Infusion	3	3
No Visual Prompts/Feedback	3	3
Circuit Failure	3	3
Pumping Stopped	2	2
Pumping Problem	2	2
Material Deformation	2	2
Increase in Pressure	2	2
Melted	2	2
Pressure Problem	2	2
Mechanical Jam	2	2
Device Contaminated During Manufacture or Shipping	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Material Puncture/Hole	1	1
Electrical Power Problem	1	1
Thermal Decomposition of Device	1	1
Inaccurate Flow Rate	1	1
Incorrect Measurement	1	1
Break	1	1
Component Misassembled	1	1
Material Split, Cut or Torn	1	1
Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	341	341
Hemorrhage/Blood Loss/Bleeding	93	93
No Consequences Or Impact To Patient	43	43
Hemolysis	20	20
Insufficient Information	20	20
Cardiac Arrest	18	18
Low Oxygen Saturation	13	13
No Patient Involvement	12	12
No Known Impact Or Consequence To Patient	4	4
Viral Infection	4	4
Low Blood Pressure/ Hypotension	4	4
Hematuria	3	3
Hemolytic Anemia	3	3
Thrombosis/Thrombus	3	3
Respiratory Failure	3	3
Brain Injury	2	2
Cardiogenic Shock	2	2
Myocardial Infarction	2	2
Air Embolism	1	1
Death	1	1
Abnormal Blood Gases	1	1
Anemia	1	1
Blood Loss	1	1
Cardiopulmonary Arrest	1	1
Hypoglycemia	1	1
Heart Failure/Congestive Heart Failure	1	1
Embolism	1	1
Thrombocytopenia	1	1
Reduced Blood Flow	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Fresenius Medical Care Holdings, Inc.	II	May-15-2024
2	Fresenius Medical Care Holdings, Inc.	II	Feb-04-2022