TPLC - Total Product Life Cycle

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Device	infusor, pressure, for i.v. bags
Regulation Description	Pressure infusor for an I.V. bag.
Product Code	KZD
Regulation Number	880.5420
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	35	35
Leak/Splash	33	33
Material Split, Cut or Torn	17	17
Material Integrity Problem	14	14
Inflation Problem	14	14
Pressure Problem	12	12
Decrease in Pressure	8	8
Unintended Deflation	8	8
Disconnection	7	7
Detachment of Device or Device Component	7	7
Device Markings/Labelling Problem	5	5
Mechanical Problem	5	5
Break	4	4
Crack	4	4
Fluid/Blood Leak	4	4
Infusion or Flow Problem	4	4
Fracture	3	3
Failure to Zero	3	3
Tear, Rip or Hole in Device Packaging	3	3
Defective Device	3	3
Connection Problem	2	2
Insufficient Information	2	2
Inaccurate Delivery	2	2
Material Fragmentation	2	2
Product Quality Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Wrong Label	2	2
Incomplete or Inadequate Connection	2	2
Device Handling Problem	2	2
Explosion	1	1
Inadequate User Interface	1	1
Failure to Deflate	1	1
Air/Gas in Device	1	1
Material Rupture	1	1
Material Separation	1	1
Use of Device Problem	1	1
Backflow	1	1
Deflation Problem	1	1
Burst Container or Vessel	1	1
Contamination	1	1
No Display/Image	1	1
False Positive Result	1	1
Filling Problem	1	1
Failure to Infuse	1	1
Obstruction of Flow	1	1
Microbial Contamination of Device	1	1
Appropriate Term/Code Not Available	1	1
Device Sensing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	144	144
Insufficient Information	27	27
Air Embolism	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Urinary Tract Infection	2	2
Arrhythmia	1	1
Respiratory Arrest	1	1
Embolism/Embolus	1	1
Atrial Fibrillation	1	1
Cardiac Arrest	1	1
Electrolyte Imbalance	1	1
Foreign Body In Patient	1	1
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1