TPLC - Total Product Life Cycle

• Device: system/device, pharmacy compounding
• Product Code: NEP
• Regulation Number: 880.5440
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2018	65	66
2019	137	144
2020	80	80
2021	130	130
2022	77	77
2023	74	74

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	144	144
Leak/Splash	102	102
Break	100	106
Mechanical Problem	83	83
Application Program Problem: Dose Calculation Error	48	48
Output Problem	41	41
Disconnection	38	38
Incorrect, Inadequate or Imprecise Result or Readings	37	37
Application Program Problem	30	30
Product Quality Problem	24	24
Inadequate User Interface	24	24
Failure to Align	18	18
Defective Component	11	11
Crack	11	11
Device Contamination with Chemical or Other Material	10	12
Contamination	8	8
Contamination of Device Ingredient or Reagent	7	7
Component Missing	7	7
Improper or Incorrect Procedure or Method	7	7
Improper Flow or Infusion	7	7
Unexpected Shutdown	6	6
Loose or Intermittent Connection	6	6
Incorrect Measurement	5	5
Thermal Decomposition of Device	5	5
Microbial Contamination of Device	5	5
Air/Gas in Device	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Wireless Communication Problem	4	4
Material Split, Cut or Torn	4	4
Material Puncture/Hole	4	4
Device Markings/Labelling Problem	4	4
Fail-Safe Problem	4	4
Precipitate in Device or Device Ingredient	4	4
Device Emits Odor	3	3
Device Alarm System	3	3
Hole In Material	3	3
Difficult to Open or Close	3	3
Material Integrity Problem	3	3
Material Twisted/Bent	3	3
Use of Device Problem	3	3
Expiration Date Error	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Application Program Problem: Medication Error	3	3
Inaccurate Information	2	2
Pumping Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Data Problem	2	2
Device Dislodged or Dislocated	2	2
Tear, Rip or Hole in Device Packaging	2	2
Labelling, Instructions for Use or Training Problem	2	2
Degraded	2	2
Material Opacification	2	2
Corroded	2	2
Application Program Problem: Parameter Calculation Error	2	2
Device Difficult to Program or Calibrate	1	1
Material Rupture	1	1
Short Fill	1	1
Smoking	1	1
Unsealed Device Packaging	1	1
Melted	1	1
Misassembled	1	1
Nonstandard Device	1	1
Use of Incorrect Control/Treatment Settings	1	1
Defective Alarm	1	1
Fracture	1	1
Material Fragmentation	1	1
No Display/Image	1	1
Electrical /Electronic Property Problem	1	1
Filling Problem	1	1
Device Operates Differently Than Expected	1	1
Device Operational Issue	1	1
Detachment of Device or Device Component	1	1
Free or Unrestricted Flow	1	1
Human-Device Interface Problem	1	1
Compatibility Problem	1	1
Infusion or Flow Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Communication or Transmission Problem	1	1
Calibration Problem	1	1
Device Displays Incorrect Message	1	1
Date/Time-Related Software Problem	1	1
Inaccurate Delivery	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Unexpected Color	1	1
Physical Resistance/Sticking	1	1
Device Fell	1	1
Power Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	246	246
No Known Impact Or Consequence To Patient	145	145
No Patient Involvement	125	132
Insufficient Information	23	23
No Consequences Or Impact To Patient	12	13
No Information	6	6
Hyperglycemia	5	5
Electrolyte Imbalance	3	3
Dehydration	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B Braun Medical, Inc.	II	Dec-23-2020
2	B. Braun Medical, Inc.	II	Jul-03-2018
3	Baxter Healthcare Corporation	I	Jul-22-2022
4	OmniCell, Inc.	II	May-22-2023
5	Smiths Medical ASD Inc.	II	Apr-21-2021