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	273	274
Infusion or Flow Problem	20	20
No Audible Alarm	18	18
Incorrect, Inadequate or Imprecise Result or Readings	18	18
Device Sensing Problem	14	14
Output Problem	13	13
Suction Problem	13	20
Unexpected Shutdown	8	8
No Flow	6	6
Tear, Rip or Hole in Device Packaging	6	6
Device Alarm System	5	5
No Apparent Adverse Event	5	5
Suction Failure	4	4
Mechanical Problem	3	3
Calibration Problem	3	3
Incorrect Measurement	3	3
Pressure Problem	2	2
Sensing Intermittently	2	2
Device Contamination with Body Fluid	2	2
No Visual Prompts/Feedback	2	2
Erratic Results	2	2
Failure to Sense	2	2
Unintended Application Program Shut Down	2	2
Gas/Air Leak	2	2
Inaccurate Delivery	2	2
Under-Sensing	2	2
Decrease in Pressure	2	2
Insufficient Flow or Under Infusion	2	2
Electrical Shorting	2	2
Electrical /Electronic Property Problem	1	1
Incorrect Interpretation of Signal	1	1
Unintended System Motion	1	1
Appropriate Term/Code Not Available	1	1
Protective Measures Problem	1	1
Failure to Calibrate	1	1
Increase in Pressure	1	2
Defective Alarm	1	1
Failure to Fire	1	1
Low Readings	1	1
Poor Visibility	1	1
Inaccurate Flow Rate	1	1
Improper Flow or Infusion	1	6
Use of Device Problem	1	1
Imprecision	1	1
Failure to Deliver	1	1
Pumping Stopped	1	1
Therapeutic or Diagnostic Output Failure	1	1
Defective Component	1	1
Insufficient Information	1	1
Incomplete or Inadequate Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	424	438
Low Oxygen Saturation	7	7
No Consequences Or Impact To Patient	3	3
Hypoventilation	2	2
Abnormal Blood Gases	2	2
No Patient Involvement	2	2
Insufficient Information	2	2
Hypoxia	2	2
Ischemia	1	1
Cardiac Arrest	1	1
Respiratory Insufficiency	1	1