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	104	104
Leak/Splash	46	46
Unable to Obtain Readings	44	44
Incorrect, Inadequate or Imprecise Result or Readings	31	31
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	12	12
Device Sensing Problem	10	10
No Display/Image	9	9
Loose or Intermittent Connection	9	9
Air/Gas in Device	9	9
Disconnection	8	8
Pressure Problem	7	7
Crack	6	6
Connection Problem	6	6
Tear, Rip or Hole in Device Packaging	6	6
Break	5	5
Fracture	5	5
Obstruction of Flow	5	5
Inappropriate Waveform	4	4
Defective Device	4	4
Contamination	4	4
Imprecise or Erratic Results	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
Defective Component	2	2
Detachment of Device or Device 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
Difficult to Remove	1	1
Material Puncture/Hole	1	1
Pacing Problem	1	1
Increase in Pressure	1	1
Flushing Problem	1	1
Device Markings/Labelling Problem	1	1
Inaccurate Information	1	1
High Sensing Threshold	1	1
Device Damaged Prior to Use	1	1
Device Alarm System	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	331	331
Insufficient Information	18	18
Heartburn/Indigestion	1	1
Ischemic Heart Disease	1	1
Valvular Insufficiency/ Regurgitation	1	1
Dyspnea	1	1
Perforation of Vessels	1	1

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