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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
BBK TECHNOLOGY LLC
  SUBSTANTIALLY EQUIVALENT 1
BIO-RAD MEDICAL DIAGNOSTICS GMBH
  SUBSTANTIALLY EQUIVALENT 1
BIOLIFE PLASMA SERVICES L.P. - BAXALTA US INC
  SUBSTANTIALLY EQUIVALENT 2
BIOLIFE PLASMA SERVICES LP
  SUBSTANTIALLY EQUIVALENT 5
BIOMAT USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIQ-HEALTH SOLUTIONS, LDA
  SUBSTANTIALLY EQUIVALENT 1
BLOOD BANK COMPUTER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
BUOY SOFTWARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CALIMEX USA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CARTER BLOODCARE
  SUBSTANTIALLY EQUIVALENT 2
COMMUNITY BLOOD CENTERS OF SOUTH FLORIDA
  SUBSTANTIALLY EQUIVALENT 1
CPSI
  SUBSTANTIALLY EQUIVALENT 1
CSL BEHRING AG
  SUBSTANTIALLY EQUIVALENT 1
CSL PLASMA
  SUBSTANTIALLY EQUIVALENT 3
DATA INNOVATIONS LLC
  SUBSTANTIALLY EQUIVALENT 3
DEPARTMENT OF VETERANS AFFAIRS
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 2
DULEY HOPKINS AND ASSOCIATES
  SUBSTANTIALLY EQUIVALENT 1
ECLYPSIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EPIC SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
FENWAL INC
  SUBSTANTIALLY EQUIVALENT 1
GPI USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
HAEMONETICS CORPORATION SOFTWARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 5
HEADSPRING HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
HEALTHCARE MANAGEMENT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTHCARE-ID, INC.
  SUBSTANTIALLY EQUIVALENT 5
HEMASOFT SOFTWARE SL
  SUBSTANTIALLY EQUIVALENT 3
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
IT SYNERGISTICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
KEDRION S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
LATTICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE PLASMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFESOUTH COMMUNITY BLOOD CENTERS INC.
  SUBSTANTIALLY EQUIVALENT 3
MAK-SYSTEM GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAK-SYSTEM SA INTERNATIONAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
MCKESSON PROVIDER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INFORMATION TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIWARE INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
NOVARTIS VACCINES AND DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PATIENTSAFE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ROWNY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANGUIN INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
SCC SOFT COMPUTER
  SUBSTANTIALLY EQUIVALENT 7
SOFTOV LTD
  SUBSTANTIALLY EQUIVALENT 1
STRATEC BIOMEDICAL UK LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SUNQUEST INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SYSLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 4
WELLSKY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WYNDGATE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2014 16 16
2015 3 3
2016 9 9
2017 8 8
2018 12 12
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 13 13
Nonstandard Device 9 9
Application Program Problem 8 8
Patient Data Problem 7 7
Improper or Incorrect Procedure or Method 6 6
Aspiration Issue 5 5
Failure to Deliver 5 5
Device Operates Differently Than Expected 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Device Alarm System 4 4
Use of Device Problem 4 4
Data Problem 4 4
Programming Issue 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Loss of Data 2 2
Device Markings/Labelling Problem 2 2
Device Displays Incorrect Message 2 2
Use of Incorrect Control/Treatment Settings 2 2
Incorrect Software Programming Calculations 2 2
Output Problem 2 2
Insufficient Information 2 2
Application Program Problem: Medication Error 2 2
Appropriate Term/Code Not Available 1 1
Problem with Software Installation 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Difficult to Program or Calibrate 1 1
Product Quality Problem 1 1
Failure to Transmit Record 1 1
Smoking 1 1
Device Inoperable 1 1
Suction Problem 1 1
Application Program Problem: Dose Calculation Error 1 1
False Positive Result 1 1
Failure to Convert to Back-Up 1 1
Break 1 1
No Device Output 1 1
Sparking 1 1
Malposition of Device 1 1
Application Network Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Communication or Transmission Problem 1 1
Operating System Becomes Nonfunctional 1 1
Device Operational Issue 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 32 32
Insufficient Information 11 11
No Clinical Signs, Symptoms or Conditions 11 11
Death 5 5
No Consequences Or Impact To Patient 5 5
No Information 4 4
No Patient Involvement 4 4
Overdose 3 3
No Code Available 2 2
Unspecified Blood or Lymphatic problem 1 1
Fatigue 1 1
Not Applicable 1 1
Shock 1 1
Swelling 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Blurred Vision 1 1
Dizziness 1 1
Complaint, Ill-Defined 1 1
Toxicity 1 1
Loss of consciousness 1 1
Sweating 1 1
Palpitations 1 1
Confusion/ Disorientation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II May-16-2018
2 SCC Soft Computer II Nov-15-2010
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