TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	35	35
Material Fragmentation	28	28
Leak/Splash	25	25
Incorrect Measurement	10	10
Difficult to Insert	8	8
Crack	8	8
Uncoiled	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Sticking	4	4
Material Rupture	3	3
Entrapment of Device	3	3
Material Integrity Problem	3	3
Connection Problem	3	3
Fluid/Blood Leak	2	2
Fracture	2	2
Appropriate Term/Code Not Available	2	2
False Reading From Device Non-Compliance	1	1
Disconnection	1	1
Device Alarm System	1	1
Retraction Problem	1	1
Misconnection	1	1
Unable to Obtain Readings	1	1
Delamination	1	1
Device Operates Differently Than Expected	1	1
Improper Device Output	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Twisted/Bent	1	1
Mechanical Jam	1	1
Packaging Problem	1	1
Insufficient Information	1	1
Improper or Incorrect Procedure or Method	1	1
Incomplete or Missing Packaging	1	1
Failure to Advance	1	1
Split	1	1
Physical Resistance	1	1
Defective Device	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	52	52
No Clinical Signs, Symptoms or Conditions	50	50
No Known Impact Or Consequence To Patient	19	19
Foreign Body In Patient	7	7
Insufficient Information	4	4
Device Embedded In Tissue or Plaque	4	4
Ischemia	4	4
Hemorrhage/Bleeding	3	3
Infarction, Cerebral	2	2
No Information	2	2
No Patient Involvement	2	2
Vascular Dissection	2	2
Hematoma	1	1
Air Embolism	1	1
Occlusion	1	1
Thrombosis	1	1
Sudden Cardiac Death	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	ICU Medical, Inc.	II	Dec-22-2018