TPLC - Total Product Life Cycle

• Device: set, i.v. fluid transfer
• Product Code: LHI
• Regulation Number: 880.5440
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVCARE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AEA SRL
	SUBSTANTIALLY EQUIVALENT	1
AVENIR PERFORMANCE EUROPEENNE MEDICAL (APEM)
	SUBSTANTIALLY EQUIVALENT	2
AVENIR PERFORMANCE EUROPÉENNE MEDICAL (APEM)
	SUBSTANTIALLY EQUIVALENT	1
B. BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
FRESENIUS KABI AG
	SUBSTANTIALLY EQUIVALENT	1
GCMEDICA ENTERPRISE LTD., (WUXI)
	SUBSTANTIALLY EQUIVALENT	1
ICU MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL MEDICAL INDUSTRIES INC.
	SUBSTANTIALLY EQUIVALENT	1
IPAX, INC
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OMNICELL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SFM MEDICAL DEVICES GMBH
	SUBSTANTIALLY EQUIVALENT	1
SOL-MILLENNIUM MEDICAL GROUP
	SUBSTANTIALLY EQUIVALENT	1
WEST PHARMA SERVICES IL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
WEST PHARMACEUTICAL SERVICES AZ, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	1497	1497
2019	1633	1789
2020	1167	1167
2021	929	929
2022	1834	1834

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	4077	4165
Device Contamination with Chemical or Other Material	983	1045
Leak/Splash	289	289
Device Displays Incorrect Message	252	252
Infusion or Flow Problem	211	211
Break	165	165
Protective Measures Problem	134	134
Material Puncture/Hole	107	107
Disconnection	98	103
Defective Device	98	98
Contamination /Decontamination Problem	92	92
Device Alarm System	79	79
Defective Component	75	75
Free or Unrestricted Flow	67	67
Output Problem	60	60
Nonstandard Device	60	60
Therapeutic or Diagnostic Output Failure	49	49
Difficult to Open or Close	34	34
Air/Gas in Device	31	31
Improper Flow or Infusion	26	26
No Flow	24	24
Detachment of Device or Device Component	24	24
Display or Visual Feedback Problem	24	24
Crack	23	23
Component Missing	20	20
Unsealed Device Packaging	19	21
Material Perforation	18	18
Loose or Intermittent Connection	18	18
Excess Flow or Over-Infusion	18	18
Insufficient Information	18	18
Failure to Align	16	16
Hole In Material	14	14
Filling Problem	13	13
Material Rupture	13	13
Material Split, Cut or Torn	13	13
Noise, Audible	12	12
Pumping Stopped	11	11
Fitting Problem	11	11
Contamination	11	11
Complete Blockage	10	10
Insufficient Flow or Under Infusion	10	10
Use of Device Problem	10	10
Material Deformation	10	10
Gas/Air Leak	10	10
Tear, Rip or Hole in Device Packaging	10	10
Device Markings/Labelling Problem	10	10
Device Operates Differently Than Expected	10	10
Connection Problem	10	10
Material Twisted/Bent	9	9
Patient Device Interaction Problem	9	9
Pressure Problem	9	9
Material Opacification	9	9
Misassembled	8	8
Product Quality Problem	8	8
Material Separation	8	8
Volume Accuracy Problem	7	7
Device Difficult to Setup or Prepare	7	7
Failure to Prime	7	7
Particulates	7	7
Backflow	7	7
Mechanical Problem	7	7
Pumping Problem	7	7
Material Integrity Problem	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Obstruction of Flow	6	6
Cut In Material	6	6
Delivered as Unsterile Product	6	6
Improper or Incorrect Procedure or Method	6	6
Precipitate in Device or Device Ingredient	6	6
Priming Problem	6	6
Increase in Pressure	5	5
Material Discolored	5	5
Structural Problem	5	5
Inaccurate Delivery	5	5
Appropriate Term/Code Not Available	5	5
Incomplete or Inadequate Connection	5	5
Packaging Problem	5	5
Material Protrusion/Extrusion	5	5
Device Contaminated During Manufacture or Shipping	4	4
Audible Prompt/Feedback Problem	4	4
Failure to Infuse	4	4
Failure to Deliver	4	4
Difficult or Delayed Activation	4	4
Inflation Problem	4	4
Partial Blockage	4	7
Defective Alarm	4	4
Device Slipped	4	4
Unable to Obtain Readings	3	3
Reflux within Device	3	4
Failure to Power Up	3	3
Labelling, Instructions for Use or Training Problem	3	3
False Alarm	3	3
Inaccurate Flow Rate	3	3
Device Damaged Prior to Use	3	3
Device Fell	3	3
Unexpected Shutdown	3	3
Scratched Material	3	3
Activation Failure	2	2
Component Misassembled	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	3374	3470
No Clinical Signs, Symptoms or Conditions	2063	2063
No Consequences Or Impact To Patient	561	565
Insufficient Information	439	439
No Known Impact Or Consequence To Patient	414	470
No Information	55	55
Dyspnea	29	29
Headache	21	21
No Code Available	16	16
Pain	13	13
Dizziness	10	10
Diarrhea	8	8
Fatigue	7	7
Chest Pain	7	7
Nausea	7	7
Hemorrhage/Bleeding	6	6
Malaise	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Chemical Exposure	5	5
Anxiety	3	3
Vomiting	3	3
Arrhythmia	3	3
Itching Sensation	2	2
Hot Flashes/Flushes	2	2
Tachycardia	2	2
Premature Labor	2	2
Low Oxygen Saturation	2	2
Swelling/ Edema	2	2
Underdose	2	2
Peripheral Edema	1	1
Shaking/Tremors	1	1
Blood Loss	1	1
Thromboembolism	1	1
Hypervolemia	1	1
Patient Problem/Medical Problem	1	1
Syncope/Fainting	1	1
Heart Failure/Congestive Heart Failure	1	1
Cough	1	1
Respiratory Insufficiency	1	1
Unspecified Respiratory Problem	1	1
Gastroesophageal Burn	1	1
Unspecified Gastrointestinal Problem	1	1
Skin Inflammation/ Irritation	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Decreased Appetite	1	1
Pallor	1	1
Diaphoresis	1	1
Discomfort	1	1
Arthralgia	1	1
Rash	1	1
Red Eye(s)	1	1
Skin Discoloration	1	1
Swelling	1	1
Muscle Weakness	1	1
Low Blood Pressure/ Hypotension	1	1
Hypoxia	1	1
Exposure to Body Fluids	1	1
Cardiac Arrest	1	1
Abdominal Pain	1	1
Adult Respiratory Distress Syndrome	1	1
Purulent Discharge	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	B. Braun Medical, Inc.	II	Mar-07-2022
2	Baxter Healthcare Corporation	II	Aug-24-2022
3	Baxter Healthcare Corporation	II	Oct-21-2019
4	Baxter Healthcare Corporation	II	May-22-2018
5	International Medical Industries, Inc.	II	Jan-07-2023
6	Medimop Medical Projects Ltd.	II	Mar-12-2018
7	WEST PHARMA. SERVICES IL, LTD	I	Jan-28-2019