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
Computer Software Problem	13	13
Patient Device Interaction 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
Volume Accuracy Problem	4	4
Air/Gas in Device	4	4
Battery Problem	4	4
Packaging Problem	3	3
Defective Device	3	3
Leak/Splash	3	3
Device Displays Incorrect Message	3	3
Display or Visual Feedback Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Thermal Decomposition of Device	3	3
Improper Flow or Infusion	3	3
Inaccurate Flow Rate	2	2
Obstruction of Flow	2	2
Free or Unrestricted Flow	2	2
Product Quality Problem	2	2
Overheating of Device	2	2
Connection Problem	2	2
No Audible Alarm	2	2
Power Problem	2	2
Failure to Calibrate	2	2
Activation, Positioning or Separation Problem	2	2
Crack	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Output Problem	2	2
Insufficient Information	2	2
Wireless Communication Problem	2	2
Communication or Transmission Problem	2	2
Inadequate Lubrication	1	1
Low Audible Alarm	1	1
Appropriate Term/Code Not Available	1	1
Inaccurate Delivery	1	1
Defective Alarm	1	1
Failure to Eject	1	1
Physical Resistance/Sticking	1	1
Smoking	1	1
Therapeutic or Diagnostic Output Failure	1	1
Defective Component	1	1
Problem with Software Installation	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
Blood Loss	1	1
Chemical Exposure	1	1
Hyperglycemia	1	1
Inadequate Pain Relief	1	1
Headache	1	1