TPLC - Total Product Life Cycle

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Device	adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
Product Code	DTL
Regulation Number	870.4290
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	323	323
Human-Device Interface Problem	123	123
Loose or Intermittent Connection	118	118
Air/Gas in Device	58	58
Fluid/Blood Leak	36	36
Improper or Incorrect Procedure or Method	16	16
Display or Visual Feedback Problem	16	16
Contamination /Decontamination Problem	15	15
Physical Resistance/Sticking	14	14
Unstable	10	10
Defective Device	10	10
Fitting Problem	7	7
Break	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Inflation Problem	7	7
Material Deformation	7	7
Device-Device Incompatibility	6	6
Crack	6	6
Tear, Rip or Hole in Device Packaging	4	4
Material Puncture/Hole	3	3
Deflation Problem	3	3
Fracture	3	3
No Apparent Adverse Event	3	3
Detachment of Device or Device Component	3	3
Gas/Air Leak	3	3
Product Quality Problem	3	3
Noise, Audible	2	2
Mechanical Problem	2	2
Output Problem	2	2
Unsealed Device Packaging	2	2
Contamination	2	2
Device Contamination with Chemical or Other Material	2	2
Device Difficult to Setup or Prepare	2	2
Material Separation	2	2
Failure to Seal	1	1
Corroded	1	1
Connection Problem	1	1
Blocked Connection	1	1
Component Missing	1	1
Positioning Failure	1	1
Unable to Obtain Readings	1	1
Patient Device Interaction Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Difficult to Remove	1	1
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
Difficult to Advance	1	1
Separation Failure	1	1
Incomplete or Inadequate Connection	1	1
Device Contamination with Body Fluid	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	684	684
Air Embolism	23	23
Insufficient Information	20	20
Hemorrhage/Bleeding	11	11
Low Blood Pressure/ Hypotension	5	5
Non specific EKG/ECG Changes	3	3
Ventricular Fibrillation	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Arrhythmia	2	2
Embolism/Embolus	2	2
Myocardial Infarction	2	2
No Consequences Or Impact To Patient	2	2
Unspecified Infection	1	1
Sepsis	1	1
Ischemic Heart Disease	1	1
Cardiac Arrest	1	1
Fluid Discharge	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	May-16-2023
2	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
3	Medline Industries Inc	II	Sep-24-2021
4	Merit Medical Systems, Inc.	II	Nov-17-2025
5	Merit Medical Systems, Inc.	II	Sep-11-2025
6	Merit Medical Systems, Inc.	II	Apr-11-2022