TPLC - Total Product Life Cycle

show TPLC since

Device	transducer, blood-pressure, extravascular
Regulation Description	Extravascular blood pressure transducer.
Product Code	DRS
Regulation Number	870.2850
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	178	178
Material Separation	125	125
Disconnection	65	65
Break	57	57
Incorrect, Inadequate or Imprecise Result or Readings	41	41
Air/Gas in Device	36	36
Crack	30	30
No Flow	29	29
Incorrect Measurement	29	29
Separation Failure	28	28
Separation Problem	24	24
Inaccurate Information	23	23
Detachment of Device or Device Component	17	17
Unable to Obtain Readings	17	17
Leak/Splash	13	13
High Readings	12	12
Pressure Problem	11	11
Material Split, Cut or Torn	8	8
Low Readings	8	8
Device Sensing Problem	6	6
Material Integrity Problem	6	6
Connection Problem	5	5
Device Markings/Labelling Problem	5	5
Obstruction of Flow	5	5
Backflow	5	5
Device Contamination with Chemical or Other Material	4	4
Gas/Air Leak	4	4
Failure to Zero	4	4
Inappropriate Waveform	4	4
Output Problem	4	4
Defective Device	3	3
Difficult to Insert	3	3
Electrical /Electronic Property Problem	3	3
Improper Flow or Infusion	3	3
Mechanical Problem	3	3
Calibration Problem	3	3
Difficult to Flush	3	3
Complete Blockage	3	3
Contamination	2	2
Loss of or Failure to Bond	2	2
Deformation Due to Compressive Stress	2	2
Device Displays Incorrect Message	2	2
Loose or Intermittent Connection	2	2
Reflux within Device	2	2
Material Rupture	2	2
Material Puncture/Hole	2	2
Display Difficult to Read	2	2
Incomplete or Inadequate Connection	2	2
Failure to Calibrate	2	2
Inaccurate Delivery	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	690	690
Hemorrhage/Bleeding	49	49
Insufficient Information	29	29
Low Blood Pressure/ Hypotension	3	3
Air Embolism	2	2
Thrombosis/Thrombus	2	2
Discomfort	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
High Blood Pressure/ Hypertension	1	1
Perinatal Brain Injury	1	1
Ischemia	1	1
Chemical Exposure	1	1
Skin Discoloration	1	1
Burn(s)	1	1
Needle Stick/Puncture	1	1
Vomiting	1	1
Exposure to Body Fluids	1	1
Extravasation	1	1
Blurred Vision	1	1
No Consequences Or Impact To Patient	1	1
Respiratory Insufficiency	1	1
Headache	1	1
Loss of Vision	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Edwards Lifesciences, LLC	II	Nov-29-2023
2	MEDLINE INDUSTRIES, LP - Northfield	II	Mar-21-2025
3	Smiths Medical ASD Inc.	II	Apr-21-2021
4	Smiths Medical Asd Inc	II	Jan-17-2024