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
CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ELITE BIOMEDICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
GILERO, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	61	66
2022	39	55
2023	27	27
2024	41	41
2025	36	36
2026	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	46	46
Device Alarm System	31	33
Failure to Infuse	15	15
Computer Software Problem	14	14
Patient Device Interaction Problem	10	10
Intermittent Communication Failure	7	7
Protective Measures Problem	7	10
Material Integrity Problem	6	6
Break	5	5
Infusion or Flow Problem	5	6
Excess Flow or Over-Infusion	5	5
Air/Gas in Device	4	4
Overheating of Device	4	4
Device Contamination with Chemical or Other Material	3	6
Mechanical Problem	3	3
Packaging Problem	3	3
Improper Flow or Infusion	3	5
Battery Problem	3	3
Defective Device	3	3
Product Quality Problem	2	2
Inaccurate Flow Rate	2	7
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Power Problem	2	2
Insufficient Information	2	2
Loose or Intermittent Connection	2	2
Device Displays Incorrect Message	2	2
Output Problem	2	3
Communication or Transmission Problem	2	2
Volume Accuracy Problem	2	2
Activation, Positioning or Separation Problem	2	2
Circuit Failure	2	2
Appropriate Term/Code Not Available	1	1
Failure to Calibrate	1	1
Failure to Cycle	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Inaccurate Delivery	1	3
Fluid/Blood Leak	1	1
Low Audible Alarm	1	3
Free or Unrestricted Flow	1	1
Electrical Shorting	1	1
Detachment of Device or Device Component	1	1
Telemetry Discrepancy	1	1
Failure to Prime	1	1
Device Emits Odor	1	1
False Alarm	1	1
Audible Prompt/Feedback Problem	1	2
Insufficient Flow or Under Infusion	1	1
Inaccurate Synchronization	1	1
Key or Button Unresponsive/not Working	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	137	144
Insufficient Information	50	63
No Information	5	5
Erythema	5	5
Pain	5	5
Swelling/ Edema	5	5
No Patient Involvement	3	3
Unspecified Infection	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
No Consequences Or Impact To Patient	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