TPLC - Total Product Life Cycle

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Device	pump, portable, aspiration (manual or powered)
Product Code	BTA
Regulation Number	878.4780
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANEST IWATA SPARMAX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ANOXIA MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
AROA BIOSURGERY LTD.
	SUBSTANTIALLY EQUIVALENT	1
DRW MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
GEON CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GI SUPPLY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN DESIDA TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XINLIANFENG TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
SOMAVAC MEDICAL SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	12	12
Gas/Air Leak	6	6
Battery Problem	5	5
Premature Discharge of Battery	4	4
Mechanical Problem	3	3
No Apparent Adverse Event	3	3
Suction Failure	3	3
Mechanical Jam	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defective Device	2	2
Crack	2	2
Fire	1	1
Fluid/Blood Leak	1	1
Fracture	1	1
Leak/Splash	1	1
Sparking	1	1
Patient-Device Incompatibility	1	1
Complete Blockage	1	1
Component Incompatible	1	1
Device Emits Odor	1	1
No Device Output	1	1
Increase in Pressure	1	1
Failure to Pump	1	1
Smoking	1	1
Defective Component	1	1
Obstruction of Flow	1	1
Loss of Data	1	1
Improper Flow or Infusion	1	1
Compatibility Problem	1	1
Infusion or Flow Problem	1	1
Unexpected Shutdown	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
Insufficient Information	6	6
Hemothorax	6	6
No Known Impact Or Consequence To Patient	5	5
No Consequences Or Impact To Patient	3	3
Pneumothorax	2	2
Airway Obstruction	2	2
Stroke/CVA	2	2
Death	2	2
No Code Available	2	2
Ruptured Aneurysm	1	1
Embolism/Embolus	1	1
No Information	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Dyspnea	1	1
Pulmonary Emphysema	1	1
Hemorrhage/Bleeding	1	1
Cardiac Arrest	1	1
Cardiopulmonary Arrest	1	1
Tachycardia	1	1
Injury	1	1
Extubate	1	1
Low Oxygen Saturation	1	1
Increased Respiratory Rate	1	1
Blood Loss	1	1
No Patient Involvement	1	1
Thromboembolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medela AG Medical Technology	II	Apr-27-2021
2	Ohio Medical Corporation	II	Jan-11-2022
3	R A Medical Services	II	Sep-20-2023