TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
B. BRAUN MELSUGEN AG
	SUBSTANTIALLY EQUIVALENT	1
CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELITE BIOMEDICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
GILERO, LLC
	SUBSTANTIALLY EQUIVALENT	1
WELLDOC, INC
	SUBSTANTIALLY EQUIVALENT	1
WELLDOC, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Alarm System	37	37
Fluid/Blood Leak	15	15
Patient Device Interaction Problem	13	13
Computer Software Problem	13	13
Infusion or Flow Problem	13	13
Insufficient Flow or Under Infusion	12	12
Protective Measures Problem	9	9
Excess Flow or Over-Infusion	9	9
Charging Problem	7	7
Mechanical Problem	6	6
Break	5	5
Material Integrity Problem	5	5
Air/Gas in Device	4	4
Battery Problem	4	4
Volume Accuracy Problem	4	4
Device Contamination with Chemical or Other Material	3	3
Thermal Decomposition of Device	3	3
Display or Visual Feedback Problem	3	3
Device Displays Incorrect Message	3	3
Defective Device	3	3
Improper Flow or Infusion	3	3
Packaging Problem	3	3
Leak/Splash	3	3
Connection Problem	2	2
Failure to Calibrate	2	2
No Audible Alarm	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Power Problem	2	2
Product Quality Problem	2	2
Free or Unrestricted Flow	2	2
Obstruction of Flow	2	2
Inaccurate Flow Rate	2	2
Activation, Positioning or Separation Problem	2	2
Communication or Transmission Problem	2	2
Overheating of Device	2	2
Insufficient Information	2	2
Wireless Communication Problem	2	2
Crack	2	2
Output Problem	2	2
Inadequate Lubrication	1	1
Failure to Sense	1	1
Electrical /Electronic Property Problem	1	1
Smoking	1	1
Defective Component	1	1
Physical Resistance/Sticking	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Eject	1	1
Material Puncture/Hole	1	1
Inaccurate Synchronization	1	1
Audible Prompt/Feedback Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	72	72
Insufficient Information	48	48
No Consequences Or Impact To Patient	42	42
No Patient Involvement	17	17
No Information	16	16
No Known Impact Or Consequence To Patient	7	7
Pain	6	6
Erythema	5	5
Swelling/ Edema	5	5
High Blood Pressure/ Hypertension	2	2
Unspecified Infection	2	2
Overdose	2	2
Endocarditis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Chemical Exposure	1	1
Blood Loss	1	1
Hyperglycemia	1	1
Headache	1	1
Inadequate Pain Relief	1	1