TPLC - Total Product Life Cycle

• Device: circuit, breathing (w connector, adaptor, y piece)
• Product Code: CAI
• Regulation Number: 868.5240
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2017	154	154
2018	39	39
2019	62	62
2020	71	71
2021	138	138
2022	110	110

Device Problems	MDRs with this Device Problem	Events in those MDRs
Disconnection	129	129
Leak/Splash	105	105
Product Quality Problem	102	102
Gas Leak	97	97
Crack	26	26
Loose or Intermittent Connection	20	20
Connection Problem	16	16
Detachment of Device or Device Component	16	16
Fitting Problem	15	15
Defective Component	14	14
Material Integrity Problem	10	10
Material Puncture/Hole	9	9
Component Missing	9	9
Break	8	8
Fluid Leak	7	7
Fracture	7	7
Material Deformation	6	6
Material Split, Cut or Torn	6	6
Gas Output Problem	5	5
Air Leak	5	5
Occlusion Within Device	5	5
Contamination /Decontamination Problem	5	5
Device Displays Incorrect Message	4	4
Device Operates Differently Than Expected	4	4
Material Separation	4	4
Inflation Problem	4	4
Insufficient Information	4	4
Separation Problem	3	3
Air/Gas in Device	3	3
Misconnection	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Pressure Problem	3	3
Obstruction of Flow	3	3
Device Damaged Prior to Use	3	3
Microbial Contamination of Device	2	2
Material Perforation	2	2
Improper or Incorrect Procedure or Method	2	2
Failure to Deliver	2	2
Tear, Rip or Hole in Device Packaging	2	2
Blocked Connection	2	2
Defective Device	2	2
Material Twisted/Bent	2	2
No Flow	2	2
No Pressure	2	2
Infusion or Flow Problem	2	2
Incorrect, Inadequate or Imprecise Resultor Readings	2	2
Partial Blockage	2	2
Loss of or Failure to Bond	2	2
Hole In Material	2	2
Material Fragmentation	2	2
Unintended Deflation	2	2
Physical Resistance/Sticking	2	2
Noise, Audible	2	2
Appropriate Term/Code Not Available	1	1
Premature Separation	1	1
Material Disintegration	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Device Alarm System	1	1
Defective Alarm	1	1
Complete Blockage	1	1
Detachment Of Device Component	1	1
Decoupling	1	1
Deflation Problem	1	1
Material Too Rigid or Stiff	1	1
Inadequacy of Device Shape and/or Size	1	1
Use of Device Problem	1	1
Decrease in Pressure	1	1
Difficult to Remove	1	1
Moisture Damage	1	1
Delivered as Unsterile Product	1	1
Difficult to Insert	1	1
Mechanical Problem	1	1
Melted	1	1
Misassembled	1	1
Improper Flow or Infusion	1	1
Difficult to Open or Close	1	1
Device Markings/Labelling Problem	1	1
Packaging Problem	1	1
Power Problem	1	1
Moisture or Humidity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Misassembly by Users	1	1
Deformation Due to Compressive Stress	1	1
Failure to Disconnect	1	1
Insufficient Flow or Under Infusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	210	210
No Known Impact Or Consequence To Patient	149	149
No Patient Involvement	83	83
No Consequences Or Impact To Patient	63	63
Insufficient Information	22	22
Low Oxygen Saturation	13	13
Hypoxia	10	10
Respiratory Distress	7	7
No Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hypoventilation	3	3
Foreign Body In Patient	2	2
Viral Infection	2	2
Bacterial Infection	2	2
Bradycardia	2	2
Cardiopulmonary Arrest	1	1
Death	1	1
Pulmonary Edema	1	1
Awareness during Anaesthesia	1	1
Apnea	1	1
Aspiration/Inhalation	1	1
Extubate	1	1
Swelling	1	1
Respiratory Failure	1	1
Decreased Respiratory Rate	1	1
Electric Shock	1	1
Chemical Exposure	1	1
Patient Problem/Medical Problem	1	1
Test Result	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Intersurgical Inc	II	Jun-27-2018
2	Medline Industries Inc	II	Dec-18-2019