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	61	66
2022	39	55
2023	27	27
2024	41	41
2025	36	36

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	46	46
Device Alarm System	40	42
Failure to Infuse	15	15
Computer Software Problem	14	14
Infusion or Flow Problem	13	14
Patient Device Interaction Problem	10	10
Excess Flow or Over-Infusion	9	9
Intermittent Communication Failure	7	7
Protective Measures Problem	7	10
Material Integrity Problem	6	6
Break	5	5
Mechanical Problem	5	5
Volume Accuracy Problem	5	5
Battery Problem	5	5
Charging Problem	4	4
Insufficient Flow or Under Infusion	4	4
Overheating of Device	4	4
Defective Device	4	4
Air/Gas in Device	4	4
Device Contamination with Chemical or Other Material	3	6
Communication or Transmission Problem	3	3
Packaging Problem	3	3
Fluid/Blood Leak	3	3
Device Displays Incorrect Message	3	3
Display or Visual Feedback Problem	3	3
Insufficient Information	3	3
Improper Flow or Infusion	3	5
Product Quality Problem	2	2
Free or Unrestricted Flow	2	2
Inaccurate Flow Rate	2	7
Problem with Software Installation	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Failure to Calibrate	2	2
No Audible Alarm	2	2
Power Problem	2	2
Loose or Intermittent Connection	2	2
Crack	2	2
Output Problem	2	3
Activation, Positioning or Separation Problem	2	2
Leak/Splash	2	2
Circuit Failure	2	2
Inaccurate Delivery	1	3
Appropriate Term/Code Not Available	1	1
Failure to Cycle	1	1
Electrical /Electronic Property Problem	1	1
Low Audible Alarm	1	3
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	138	145
Insufficient Information	51	64
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
No Known Impact Or Consequence To Patient	2	2
Overdose	2	2
Endocarditis	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	2
Chemical Exposure	1	1
Bradycardia	1	1
Tachycardia	1	1
Headache	1	1
Low Blood Pressure/ Hypotension	1	1

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