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	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	167	167
Insufficient Device Problem Information	91	91
Communication or Transmission Problem	90	90
Output Problem	68	68
Incorrect, Inadequate or Imprecise Result or Readings	65	65
Mechanical Problem	63	63
Leak/Splash	62	62
Adverse Event Without Identified Device or Use Problem	37	37
Obstruction of Flow	12	12
Protective Measures Problem	11	11
Infusion or Flow Problem	10	10
Device Alarm System	10	10
Material Integrity Problem	8	8
Noise, Audible	7	7
Electrical /Electronic Property Problem	6	6
Improper Flow or Infusion	6	6
Crack	5	5
Air/Gas in Device	5	5
Material Separation	4	4
Defective Component	4	4
Display or Visual Feedback Problem	4	4
No Flow	4	4
Insufficient Flow or Under Infusion	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Contamination	3	3
No Visual Prompts/Feedback	3	3
Melted	2	2
Increase in Pressure	2	2
Pumping Stopped	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Deformation	2	2
Mechanical Jam	2	2
Circuit Failure	2	2
Pressure Problem	2	2
Pumping Problem	2	2
Incorrect Measurement	1	1
Inaccurate Flow Rate	1	1
Loss of Power	1	1
Material Puncture/Hole	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Electrical Power Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Thermal Decomposition of Device	1	1
Break	1	1
Component Misassembled	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	333	333
Hemorrhage/Blood Loss/Bleeding	93	93
No Consequences Or Impact To Patient	43	43
Insufficient Information	20	20
Hemolysis	20	20
Cardiac Arrest	18	18
Low Oxygen Saturation	13	13
Low Blood Pressure/ Hypotension	4	4
Viral Infection	4	4
Thrombosis/Thrombus	3	3
Hematuria	3	3
Respiratory Failure	3	3
Hemolytic Anemia	3	3
Brain Injury	2	2
Myocardial Infarction	2	2
Cardiogenic Shock	2	2
No Patient Involvement	1	1
Air Embolism	1	1
Thrombocytopenia	1	1
Hypoglycemia	1	1
No Known Impact Or Consequence To Patient	1	1
Reduced Blood Flow	1	1
Heart Failure/Congestive Heart Failure	1	1
Anemia	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