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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device set, perfusion, kidney, disposable
Product CodeKDL
Regulation Number 876.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
DR. FRANZ KOHLER CHEMIE GMBH
  SUBSTANTIALLY EQUIVALENT 1
INSTITUT GEORGES LOPEZ
  SUBSTANTIALLY EQUIVALENT 2
ORGAN RECOVERY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.A.L.F. SPA
  SUBSTANTIALLY EQUIVALENT 2
WATERS MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 30 30
2017 10 10
2019 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination of Device Ingredient or Reagent 17 17
Microbial Contamination of Device 10 10
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 4 4
Nonstandard Device 3 3
Leak/Splash 2 2
Contamination 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Device Issue 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 23 23
No Information 3 3
Fungal Infection 3 3
Fever 3 3
Urinary Tract Infection 2 2
No Consequences Or Impact To Patient 2 2
Bacterial Infection 2 2
Insufficient Information 2 2
Death 1 1
Chemical Exposure 1 1
Complete Heart Block 1 1
No Code Available 1 1
Multiple Organ Failure 1 1
Heart Failure 1 1
Complaint, Ill-Defined 1 1
Granuloma 1 1
Hematoma 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Urinary Retention 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Nov-08-2016
2 Organ Recovery Systems, Inc. II Jan-27-2017
3 Teva Pharmaceuticals USA, Inc. II Apr-18-2012
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