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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
Product CodeMMH
Regulation Number 864.9165
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ALLIANCE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
ARC-ONE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD MEDICAL DIAGNOSTICS GMBH
  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 1
CSL PLASMA
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 2
EPIC SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GPI USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEADSPRING HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMASOFT SOFTWARE SL
  SUBSTANTIALLY EQUIVALENT 2
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
KEDRION S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
LIFE PLASMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAK-SYSTEM GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCC SOFT COMPUTER
  SUBSTANTIALLY EQUIVALENT 2
SUNQUEST INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 2
WELLSKY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 3 3
2021 9 9
2022 7 7
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 6 6
Application Program Problem 6 6
Improper or Incorrect Procedure or Method 4 4
Nonstandard Device 4 4
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Use of Device Problem 2 2
Device Markings/Labelling Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Output Problem 2 2
Data Problem 2 2
Patient Data Problem 1 1
Application Program Problem: Medication Error 1 1
Therapeutic or Diagnostic Output Failure 1 1
Operating System Becomes Nonfunctional 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1
Device Displays Incorrect Message 1 1
Loss of Data 1 1
Product Quality Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Application Program Problem: Dose Calculation Error 1 1
Device Alarm System 1 1
Failure to Convert to Back-Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 11 11
No Clinical Signs, Symptoms or Conditions 11 11
No Known Impact Or Consequence To Patient 6 6
Death 2 2
No Consequences Or Impact To Patient 2 2
Confusion/ Disorientation 1 1
Overdose 1 1
Shock 1 1
Unspecified Blood or Lymphatic problem 1 1

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