TPLC - Total Product Life Cycle

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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	168	168
Material Separation	124	124
Disconnection	63	63
Break	57	57
Incorrect, Inadequate or Imprecise Result or Readings	40	40
Air/Gas in Device	31	31
No Flow	29	29
Incorrect Measurement	28	28
Separation Failure	28	28
Crack	26	26
Separation Problem	24	24
Inaccurate Information	23	23
Unable to Obtain Readings	15	15
Detachment of Device or Device Component	14	14
Leak/Splash	12	12
Pressure Problem	11	11
High Readings	11	11
Material Split, Cut or Torn	8	8
Low Readings	7	7
Material Integrity Problem	6	6
Device Sensing Problem	6	6
Device Markings/Labelling Problem	5	5
Obstruction of Flow	5	5
Output Problem	4	4
Inappropriate Waveform	4	4
Backflow	4	4
Connection Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Gas/Air Leak	4	4
Failure to Zero	4	4
Difficult to Insert	3	3
Mechanical Problem	3	3
Difficult to Flush	3	3
Electrical /Electronic Property Problem	3	3
Defective Device	3	3
Calibration Problem	3	3
Improper Flow or Infusion	3	3
Incomplete or Inadequate Connection	2	2
Inaccurate Delivery	2	2
Loss of or Failure to Bond	2	2
Material Rupture	2	2
Complete Blockage	2	2
Contamination	2	2
Deformation Due to Compressive Stress	2	2
Device Displays Incorrect Message	2	2
Failure to Calibrate	2	2
Reflux within Device	2	2
Material Puncture/Hole	2	2
Display Difficult to Read	2	2
Loose or Intermittent Connection	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	665	665
Hemorrhage/Bleeding	44	44
Insufficient Information	29	29
Low Blood Pressure/ Hypotension	3	3
Thrombosis/Thrombus	2	2
Discomfort	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
High Blood Pressure/ Hypertension	1	1
Air Embolism	1	1
Chemical Exposure	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