TPLC - Total Product Life Cycle

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Device	system/device, pharmacy compounding
Regulation Description	Intravascular administration set.
Product Code	NEP
Regulation Number	880.5440
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	73	73
Fluid/Blood Leak	70	70
Application Program Problem: Dose Calculation Error	37	37
Application Program Problem	31	32
Disconnection	30	30
Inadequate User Interface	25	26
Product Quality Problem	25	26
Device Contamination with Chemical or Other Material	18	18
Contamination	15	15
Leak/Splash	13	13
Difficult to Open or Close	10	10
Crack	10	10
Defective Component	10	10
Material Split, Cut or Torn	8	8
Air/Gas in Device	8	8
Loose or Intermittent Connection	7	7
Contamination of Device Ingredient or Reagent	7	7
Precipitate in Device or Device Ingredient	7	7
Component Missing	7	7
Unexpected Shutdown	6	6
Detachment of Device or Device Component	5	5
Device Emits Odor	5	5
Microbial Contamination of Device	5	5
Output Problem	4	4
Wireless Communication Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Fail-Safe Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Fracture	3	3
Labelling, Instructions for Use or Training Problem	3	3
Expiration Date Error	3	3
Contamination /Decontamination Problem	3	3
Application Program Problem: Medication Error	3	3
Corroded	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Tear, Rip or Hole in Device Packaging	2	2
Unexpected Color	2	2
Data Problem	2	2
Excess Flow or Over-Infusion	2	2
Material Twisted/Bent	2	2
Failure to Align	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defective Device	2	2
Filling Problem	2	2
Device Markings/Labelling Problem	2	2
Device Alarm System	2	2
Volume Accuracy Problem	2	2
Material Fragmentation	1	2
Degraded	1	1
Infusion or Flow Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	338	341
Insufficient Information	24	24
No Patient Involvement	16	16
Hyperglycemia	6	6
Electrolyte Imbalance	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Consequences Or Impact To Patient	2	2
Dehydration	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	May-29-2026
2	Baxter Healthcare Corporation	I	Jul-22-2022
3	OmniCell, Inc.	II	May-22-2023
4	Omnicell, Inc.	I	May-13-2026
5	Smiths Medical ASD Inc.	II	Apr-21-2021