TPLC - Total Product Life Cycle

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Device	probe, blood-flow, extravascular
Regulation Description	Extravascular blood flow probe.
Product Code	DPT
Regulation Number	870.2120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	68	68
Unable to Obtain Readings	44	44
Leak/Splash	42	42
Incorrect, Inadequate or Imprecise Result or Readings	26	26
Failure to Calibrate	19	19
Gas/Air Leak	19	19
Display or Visual Feedback Problem	15	15
Failure to Zero	13	13
Data Problem	13	13
Failure to Sense	11	11
Device Sensing Problem	10	10
No Display/Image	9	9
Loose or Intermittent Connection	9	9
Air/Gas in Device	9	9
Disconnection	7	7
Pressure Problem	7	7
Connection Problem	6	6
Tear, Rip or Hole in Device Packaging	6	6
Break	5	5
Crack	5	5
Fracture	5	5
Obstruction of Flow	5	5
Inappropriate Waveform	4	4
Erratic Results	4	4
Defective Device	4	4
Contamination	4	4
Calibration Problem	4	4
No Device Output	3	3
Difficult to Open or Close	3	3
Incorrect Measurement	3	3
Material Deformation	3	3
Mechanical Problem	3	3
Backflow	2	2
Detachment of Device or Device Component	2	2
Defective Component	2	2
Failure to Recalibrate	2	2
Complete Blockage	2	2
Blocked Connection	1	1
Decrease in Pressure	1	1
Excess Flow or Over-Infusion	1	1
Pacing Problem	1	1
Increase in Pressure	1	1
Material Puncture/Hole	1	1
Flushing Problem	1	1
Inaccurate Information	1	1
High Sensing Threshold	1	1
Device Markings/Labelling Problem	1	1
Device Damaged Prior to Use	1	1
Device Alarm System	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	286	286
Insufficient Information	18	18
Ischemic Heart Disease	1	1
Valvular Insufficiency/ Regurgitation	1	1
Pyrosis/Heartburn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Smiths Medical ASD, Inc.	II	Oct-23-2024