TPLC - Total Product Life Cycle

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Device	gas control unit, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass gas control unit.
Product Code	DTX
Regulation Number	870.4300
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas Output Problem	277	278
Infusion or Flow Problem	20	20
Incorrect, Inadequate or Imprecise Result or Readings	19	19
No Audible Alarm	18	18
Device Sensing Problem	14	14
Suction Problem	14	21
Output Problem	13	13
Unexpected Shutdown	8	8
Tear, Rip or Hole in Device Packaging	6	6
No Flow	6	6
Device Alarm System	5	5
No Apparent Adverse Event	5	5
Suction Failure	4	4
Calibration Problem	3	3
Incorrect Measurement	3	3
Pressure Problem	2	2
Unintended Application Program Shut Down	2	2
Insufficient Flow or Under Infusion	2	2
Imprecise or Erratic Results	2	2
Under-Sensing	2	2
Device Contamination with Body Fluid	2	2
Mechanical Problem	2	2
Failure to Sense	2	2
Electrical Shorting	2	2
No Visual Prompts/Feedback	2	2
Inaccurate Delivery	2	2
Gas/Air Leak	2	2
Sensing Intermittently	2	2
Decrease in Pressure	2	2
Poor Visibility	1	1
Imprecision	1	1
Defective Component	1	1
Incorrect Interpretation of Signal	1	1
Use of Device Problem	1	1
Pumping Stopped	1	1
Failure to Fire	1	1
Incomplete or Inadequate Connection	1	1
Unintended System Motion	1	1
Defective Alarm	1	1
Low Readings	1	1
Protective Measures Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Insufficient Device Problem Information	1	1
Inaccurate Flow Rate	1	1
Improper Flow or Infusion	1	6
Electrical /Electronic Property Problem	1	1
Increase in Suction	1	1
Increase in Pressure	1	2
Failure to Calibrate	1	1
Failure to Deliver	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	430	444
Low Oxygen Saturation	7	7
No Consequences Or Impact To Patient	3	3
Insufficient Information	2	2
Abnormal Blood Gases	2	2
Hypoxia	2	2
No Patient Involvement	2	2
Hypoventilation	2	2
Ischemia	1	1
Cardiac Arrest	1	1
Respiratory Insufficiency	1	1