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	136	136
Material Separation	130	130
Disconnection	66	66
Break	56	56
Incorrect, Inadequate or Imprecise Result or Readings	39	39
Separation Failure	28	28
No Flow	24	24
Crack	24	24
Air/Gas in Device	24	24
Separation Problem	23	23
Inaccurate Information	21	21
Incorrect Measurement	18	18
Detachment of Device or Device Component	16	16
Unable to Obtain Readings	14	14
Leak/Splash	12	12
Pressure Problem	12	12
High Readings	11	11
Material Split, Cut or Torn	8	8
Material Integrity Problem	6	6
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
Obstruction of Flow	4	4
Failure to Zero	4	4
Backflow	4	4
Electrical /Electronic Property Problem	3	3
Infusion or Flow Problem	3	3
Gas/Air Leak	3	3
Difficult to Insert	3	3
Mechanical Problem	3	3
Inappropriate Waveform	3	3
Difficult to Flush	3	3
Loss of or Failure to Bond	2	2
Contamination	2	2
Defective Device	2	2
Fail-Safe Problem	2	2
Deformation Due to Compressive Stress	2	2
Improper Flow or Infusion	2	2
Loose or Intermittent Connection	2	2
Calibration Problem	2	2
Material Puncture/Hole	2	2
Low Readings	2	2
Display Difficult to Read	2	2
Incomplete or Inadequate Connection	2	2
Inaccurate Delivery	2	2
Failure to Calibrate	2	2
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	579	579
Hemorrhage/Bleeding	38	38
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
Vomiting	1	1
Extravasation	1	1
Blurred Vision	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