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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor and/or control, level sensing, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass level sensing monitor and/or control.
Product CodeDTW
Regulation Number 870.4340
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Operational Issue 15
Device Alarm System 7
False Alarm 7
Device Displays Incorrect Message 5
Sensor 4
Monitor 4
Failure to Sense 4
Appropriate Term/Code Not Available 4
Other (for use when an appropriate device code cannot be identified) 3
Break 3
Pumping Stopped 3
Incorrect, Inadequate or Imprecise Result or Readings 2
No Display / Image 2
Delayed Alarm 2
Failure to Power Up 2
Device Sensing Problem 2
Failure to Auto Stop 1
No Flow 1
Pressure Problem 1
Bubble Detector 1
Temperature Probe 1
Insufficient Information 1
Failure to Calibrate 1
Alarm, Audible 1
Circuit Board 1
Connector 1
False Reading From Device Non-Compliance 1
No Device Output 1
Latch 1
Communication or Transmission Problem 1
Connection Problem 1
Device Operates Differently Than Expected 1
Total Device Problems 85


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