TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ARMIS BIOPHARMA, INC.
	SUBSTANTIALLY EQUIVALENT	1
BD
	SUBSTANTIALLY EQUIVALENT	1
BECTON, DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ERBE ELEKTROMEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	1
INNOVACYN, INC.
	SUBSTANTIALLY EQUIVALENT	1
INOPRO INC
	SUBSTANTIALLY EQUIVALENT	1
IRRIMAX CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
NEXT SCIENCE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPHOR, LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Delivered as Unsterile Product	215	294
Battery Problem	207	207
Detachment of Device or Device Component	191	251
No Flow	111	111
Fluid/Blood Leak	100	166
Difficult to Insert	79	79
Adverse Event Without Identified Device or Use Problem	72	72
Inability to Irrigate	72	72
Failure to Power Up	68	68
Failure to Prime	62	62
Overheating of Device	60	60
Mechanical Problem	58	58
Disconnection	57	57
Expulsion	57	57
Break	57	57
Leak/Splash	56	56
Improper Flow or Infusion	53	53
Manufacturing, Packaging or Shipping Problem	52	52
Connection Problem	45	45
Device Contaminated During Manufacture or Shipping	44	44
Defective Device	40	40
Appropriate Term/Code Not Available	38	38
Corroded	36	36
Crack	35	35
Fracture	32	50
Pressure Problem	31	31
Defective Component	30	30
Noise, Audible	29	29
Electrical /Electronic Property Problem	28	28
Biocompatibility	26	26
Infusion or Flow Problem	25	25
Smoking	25	25
Device Contamination with Chemical or Other Material	23	24
Power Problem	23	23
Packaging Problem	20	20
Material Rupture	20	20
Loose or Intermittent Connection	19	19
Melted	14	14
Suction Problem	14	14
Component Missing	12	12
Material Integrity Problem	12	12
Device Emits Odor	12	12
Inaccurate Flow Rate	11	11
Electrical Power Problem	11	11
Material Deformation	11	11
Material Frayed	10	10
No Pressure	10	10
Activation Problem	10	10
Positioning Problem	10	10
Protective Measures Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1164	1338
No Consequences Or Impact To Patient	445	489
No Known Impact Or Consequence To Patient	306	312
No Patient Involvement	196	226
Insufficient Information	48	52
Foreign Body In Patient	32	32
Post Operative Wound Infection	25	25
Impaired Healing	13	13
Injury	12	12
Hypersensitivity/Allergic reaction	11	11
No Code Available	11	11
Burning Sensation	9	9
No Information	8	8
Rash	6	6
Unspecified Infection	4	4
Not Applicable	3	3
Necrosis	3	3
Burn(s)	2	2
Dyspnea	2	2
Swelling/ Edema	2	2
Device Embedded In Tissue or Plaque	2	2
Non specific EKG/ECG Changes	1	1
Wound Dehiscence	1	1
Arrhythmia	1	1
Stroke/CVA	1	1
Sprain	1	1
Hematoma	1	1
Embolism/Embolus	1	1
Purulent Discharge	1	1
Blister	1	1
Reaction to Medicinal Component of Device	1	1
Erythema	1	1
Laceration(s)	1	1
Tissue Damage	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	IrriMAX Corporation	II	Oct-24-2019
2	Maquet Cardiovascular, LLC	II	Mar-07-2019
3	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
4	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	II	Nov-20-2018
5	Medtronic Perfusion Systems	II	May-10-2024
6	Stryker Instruments Div. of Stryker Corporation	II	Mar-28-2018