TPLC - Total Product Life Cycle

• Device: accessories, pump, infusion
• Regulation Description: Infusion pump.
• Product Code: MRZ
• Regulation Number: 880.5725
• Device Class: 2

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

MDR Year	MDR Reports	MDR Events
2020	44	44
2021	59	59
2022	39	39
2023	27	27
2024	38	38
2025	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Alarm System	38	38
Wireless Communication Problem	29	29
Computer Software Problem	14	14
Infusion or Flow Problem	13	13
Patient Device Interaction Problem	10	10
Excess Flow or Over-Infusion	7	7
Failure to Infuse	7	7
Protective Measures Problem	6	6
Break	5	5
Material Integrity Problem	5	5
Mechanical Problem	4	4
Volume Accuracy Problem	4	4
Charging Problem	4	4
Insufficient Flow or Under Infusion	4	4
Battery Problem	4	4
Air/Gas in Device	4	4
Overheating of Device	4	4
Device Contamination with Chemical or Other Material	3	3
Packaging Problem	3	3
Improper Flow or Infusion	3	3
Defective Device	3	3
Insufficient Information	3	3
Display or Visual Feedback Problem	3	3
Device Displays Incorrect Message	3	3
Fluid/Blood Leak	3	3
Power Problem	2	2
No Audible Alarm	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Problem with Software Installation	2	2
Failure to Calibrate	2	2
Crack	2	2
Inaccurate Flow Rate	2	2
Intermittent Communication Failure	2	2
Output Problem	2	2
Communication or Transmission Problem	2	2
Activation, Positioning or Separation Problem	2	2
Leak/Splash	2	2
Product Quality Problem	2	2
Free or Unrestricted Flow	2	2
Circuit Failure	2	2
Appropriate Term/Code Not Available	1	1
Failure to Cycle	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Inaccurate Delivery	1	1
Low Audible Alarm	1	1
Defective Alarm	1	1
Electrical Shorting	1	1
Detachment of Device or Device Component	1	1
Telemetry Discrepancy	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	109	109
Insufficient Information	48	48
No Consequences Or Impact To Patient	19	19
No Patient Involvement	15	15
No Information	13	13
Pain	6	6
Erythema	5	5
Swelling/ Edema	5	5
High Blood Pressure/ Hypertension	2	2
Unspecified Infection	2	2
Overdose	2	2
No Known Impact Or Consequence To Patient	2	2
Endocarditis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Chemical Exposure	1	1
Tachycardia	1	1
Headache	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD Inc.	II	Apr-15-2024