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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
Product CodeDTW
Regulation Number 870.4340
Device Class 2

MDR Year MDR Reports MDR Events
2016 22 22
2017 47 47
2018 6 6
2019 15 15
2020 2 2
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 15 15
Device Alarm System 9 9
False Alarm 8 8
Device Displays Incorrect Message 7 7
Device Sensing Problem 7 7
Device Operates Differently Than Expected 7 7
No Display/Image 6 6
Failure To Adhere Or Bond 5 5
Failure to Power Up 5 5
Failure to Sense 5 5
Appropriate Term/Code Not Available 4 4
Pumping Stopped 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Delayed Alarm 2 2
Connection Problem 2 2
Failure to Auto Stop 2 2
Material Integrity Problem 1 1
No Flow 1 1
Output Problem 1 1
Pressure Problem 1 1
Insufficient Information 1 1
Communication or Transmission Problem 1 1
Device Stops Intermittently 1 1
Out-Of-Box Failure 1 1
Failure to Calibrate 1 1
Bent 1 1
Break 1 1
Degraded 1 1
Disconnection 1 1
False Reading From Device Non-Compliance 1 1
No Device Output 1 1
Defective Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 52 52
No Patient Involvement 37 37
No Known Impact Or Consequence To Patient 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Seizures 1 1
No Information 1 1
Insufficient Information 1 1
Patient Problem/Medical Problem 1 1
Ventilator Dependent 1 1

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