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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blood establishment computer software and accessories
Regulation Description Blood establishment computer software and accessories.
Product CodeMMH
Regulation Number 864.9165
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ALLIANCE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARC-ONE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 1
BIOLIFE PLASMA SERVICES LP
  SUBSTANTIALLY EQUIVALENT 1
BIOMAT USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIQ-HEALTH SOLUTIONS, LDA
  SUBSTANTIALLY EQUIVALENT 1
BLOOD BANK COMPUTER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BUOY SOFTWARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARTER BLOODCARE
  SUBSTANTIALLY EQUIVALENT 2
CSL PLASMA
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 2
EDONORSOFT LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GPI USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
HEADSPRING HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMASOFT SOFTWARE SL
  SUBSTANTIALLY EQUIVALENT 2
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
IT SYNERGISTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
KEDRION S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
LIFE PLASMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAK-SYSTEM GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 2
SCC SOFT COMPUTER
  SUBSTANTIALLY EQUIVALENT 2
SUNQUEST INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WELLSKY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3 3
2021 9 9
2022 7 9
2023 7 7
2024 9 9
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 8 8
Application Program Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Loss of Data 4 4
Patient Data Problem 3 3
Use of Device Problem 3 3
Data Problem 3 3
Application Program Problem: Parameter Calculation Error 3 3
Improper or Incorrect Procedure or Method 3 3
Inadequate User Interface 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Date/Time-Related Software Problem 2 2
Compatibility Problem 1 1
Operating System Becomes Nonfunctional 1 1
False Negative Result 1 1
Output Problem 1 1
Device Alarm System 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Application Program Problem: Medication Error 1 3
Use of Incorrect Control/Treatment Settings 1 1
Product Quality Problem 1 1
Installation-Related Problem 1 1
Nonstandard Device 1 1
Computer System Security Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26 28
Insufficient Information 13 13
Death 1 1
Confusion/ Disorientation 1 1
Unspecified Blood or Lymphatic problem 1 1
Shock 1 1

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