TPLC - Total Product Life Cycle

• Device: pump, blood, cardiopulmonary bypass, roller type
• Regulation Description: Roller-type cardiopulmonary bypass blood pump.
• Product Code: DWB
• Regulation Number: 870.4370
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2016	318	318
2017	361	361
2018	258	258
2019	155	155
2020	79	79
2021	40	40

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Displays Incorrect Message	261	261
No Display/Image	255	255
Pumping Stopped	194	194
Pumping Problem	91	91
Appropriate Term/Code Not Available	60	60
Device Operational Issue	53	53
Failure to Pump	45	45
Display or Visual Feedback Problem	45	45
Device Operates Differently Than Expected	44	44
Failure to Power Up	26	26
Mechanical Jam	19	19
Break	17	17
Mechanical Problem	16	16
Fracture	15	15
Failure to Auto Stop	15	15
Detachment Of Device Component	15	15
Output Problem	14	14
Device Stops Intermittently	13	13
Loss of Power	11	11
Communication or Transmission Problem	9	9
Erratic or Intermittent Display	9	9
Image Display Error/Artifact	8	8
Connection Problem	7	7
Unexpected Shutdown	7	7
Device Slipped	6	6
Device Alarm System	6	6
False Alarm	6	6
Decreased Pump Speed	5	5
Detachment of Device or Device Component	5	5
Calibration Problem	4	4
Fluid Leak	4	4
Device Inoperable	4	4
Positioning Problem	4	4
Power Problem	4	4
Insufficient Flow or Under Infusion	3	3
Device Markings/Labelling Problem	3	3
Alarm Not Visible	3	3
Incorrect Measurement	3	3
No Audible Alarm	3	3
Crack	3	3
Component Missing	3	3
Activation, Positioning or SeparationProblem	3	3
Noise, Audible	3	3
Infusion or Flow Problem	3	3
Protective Measures Problem	3	3
Physical Property Issue	2	2
No Flow	2	2
Human Factors Issue	2	2
Device Issue	2	2
Use of Device Problem	2	2
Increased Pump Speed	2	2
Overheating of Device	2	2
Thermal Decomposition of Device	2	2
Leak/Splash	2	2
Electrical /Electronic Property Problem	2	2
Decrease in Pressure	2	2
Display Difficult to Read	2	2
Unintended Movement	1	1
Physical Resistance/Sticking	1	1
Intermittent Communication Failure	1	1
Product Quality Problem	1	1
Material Rupture	1	1
Inaccurate Flow Rate	1	1
Loose or Intermittent Connection	1	1
Moisture Damage	1	1
Defective Alarm	1	1
Failure to Conduct	1	1
Contamination	1	1
Intermittent Continuity	1	1
Device Sensing Problem	1	1
Improper Device Output	1	1
Inappropriate or Unexpected Reset	1	1
Material Deformation	1	1
Material Distortion	1	1
Material Integrity Problem	1	1
Device Contamination with Body Fluid	1	1
Intermittent Infusion	1	1
Difficult or Delayed Activation	1	1
Unstable	1	1
Volume Accuracy Problem	1	1
Difficult To Position	1	1
Pre Or Post-Pumping Problem	1	1
Low Audible Alarm	1	1
Signal Artifact/Noise	1	1
Bent	1	1
Charred	1	1
Complete Blockage	1	1
Use of Incorrect Control Settings	1	1
Smoking	1	1
Incorrect, Inadequate or Imprecise Resultor Readings	1	1
Material Too Rigid or Stiff	1	1
Physical Resistance	1	1
Improper Flow or Infusion	1	1
Naturally Worn	1	1
Failure to Shut Off	1	1
Device Damaged by Another Device	1	1
Difficult to Open or Close	1	1
Operating System Becomes Nonfunctional	1	1
Temperature Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	573	573
No Patient Involvement	566	566
No Clinical Signs, Symptoms or Conditions	33	33
No Known Impact Or Consequence To Patient	22	22
No Information	12	12
Death	4	4
Air Embolism	2	2
Loss of consciousness	1	1
Hemolysis	1	1
Blood Loss	1	1
Cardiac Arrest	1	1