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	165	165
Communication or Transmission Problem	90	90
Mechanical Problem	56	56
Insufficient Information	51	51
Leak/Splash	50	50
Output Problem	47	47
Incorrect, Inadequate or Imprecise Result or Readings	44	44
Adverse Event Without Identified Device or Use Problem	35	35
Obstruction of Flow	10	10
Protective Measures Problem	8	8
Device Alarm System	7	7
Infusion or Flow Problem	7	7
Noise, Audible	6	6
Improper Flow or Infusion	6	6
No Flow	4	4
Crack	4	4
Defective Component	4	4
Material Integrity Problem	4	4
Insufficient Flow or Under Infusion	3	3
Air/Gas in Device	3	3
Mechanical Jam	2	2
Melted	2	2
Increase in Pressure	2	2
Contamination /Decontamination Problem	2	2
Pumping Stopped	2	2
Contamination	2	2
Pumping Problem	2	2
Pressure Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Thermal Decomposition of Device	1	1
Inaccurate Flow Rate	1	1
Incorrect Measurement	1	1
Material Separation	1	1
Component Misassembled	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Electrical Power Problem	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Loss of Power	1	1
No Visual Prompts/Feedback	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	279	279
Hemorrhage/Bleeding	91	91
No Consequences Or Impact To Patient	43	43
Hemolysis	20	20
Insufficient Information	20	20
Low Oxygen Saturation	13	13
Cardiac Arrest	11	11
Viral Infection	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
Low Blood Pressure/ Hypotension	2	2
Air Embolism	1	1
Anemia	1	1
No Known Impact Or Consequence To Patient	1	1
No Patient Involvement	1	1
Hypoglycemia	1	1
Heart Failure/Congestive Heart Failure	1	1
Thrombocytopenia	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