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
Material Separation	127	127
Fluid/Blood Leak	120	120
Disconnection	64	64
Break	56	56
Incorrect, Inadequate or Imprecise Result or Readings	34	34
Separation Failure	28	28
Air/Gas in Device	23	23
Separation Problem	21	21
Inaccurate Information	20	20
Crack	20	20
No Flow	16	16
Detachment of Device or Device Component	15	15
Incorrect Measurement	14	14
Unable to Obtain Readings	14	14
Pressure Problem	12	12
High Readings	11	11
Leak/Splash	10	10
Material Split, Cut or Torn	8	8
Reflux within Device	5	5
Device Markings/Labelling Problem	5	5
Device Sensing Problem	5	5
Output Problem	4	4
Connection Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Backflow	4	4
Failure to Zero	4	4
Material Integrity Problem	4	4
Electrical /Electronic Property Problem	3	3
Infusion or Flow Problem	3	3
Obstruction of Flow	3	3
Difficult to Insert	3	3
Inappropriate Waveform	3	3
Mechanical Problem	3	3
Contamination	2	2
Defective Device	2	2
Loss of or Failure to Bond	2	2
Fail-Safe Problem	2	2
Deformation Due to Compressive Stress	2	2
Gas/Air Leak	2	2
Improper Flow or Infusion	2	2
Loose or Intermittent Connection	2	2
Calibration Problem	2	2
Material Puncture/Hole	2	2
Difficult to Flush	2	2
Display Difficult to Read	2	2
Incomplete or Inadequate Connection	2	2
Failure to Calibrate	2	2
No Device Output	1	1
Unintended Collision	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	539	539
Hemorrhage/Bleeding	29	29
Insufficient Information	23	23
No Consequences Or Impact To Patient	20	20
No Known Impact Or Consequence To Patient	8	8
No Patient Involvement	8	8
Blood Loss	6	6
Death	3	3
Low Blood Pressure/ Hypotension	3	3
Thrombosis/Thrombus	2	2
Discomfort	2	2
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Cardiac Arrest	1	1
Burn(s)	1	1
Extravasation	1	1
Respiratory Insufficiency	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