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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
BIOLIFE PLASMA SERVICES L.P. - BAXALTA US INC
  SUBSTANTIALLY EQUIVALENT 2
BIOMAT USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIQ-HEALTH SOLUTIONS, LDA
  SUBSTANTIALLY EQUIVALENT 1
BLOOD BANK COMPUTER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BUOY SOFTWARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARTER BLOODCARE
  SUBSTANTIALLY EQUIVALENT 3
CSL PLASMA
  SUBSTANTIALLY EQUIVALENT 2
DATA INNOVATIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPARTMENT OF VETERANS AFFAIRS
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC GRIFOLS, S. A.
  SUBSTANTIALLY EQUIVALENT 2
EDONORSOFT LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
GPI USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
HAEMONETICS CORPORATION SOFTWARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
HEADSPRING HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
HEALTHCARE-ID, INC.
  SUBSTANTIALLY EQUIVALENT 3
HEMASOFT SOFTWARE SL
  SUBSTANTIALLY EQUIVALENT 3
IMMUCOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
KEDRION S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
LIFE PLASMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFESOUTH COMMUNITY BLOOD CENTERS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAK-SYSTEM GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAK-SYSTEM SA INTERNATIONAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INFORMATION TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIWARE INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SCC SOFT COMPUTER
  SUBSTANTIALLY EQUIVALENT 2
STRATEC BIOMEDICAL UK LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SUNQUEST INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYSLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 3
WELLSKY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 13 13
Application Program Problem 8 8
Improper or Incorrect Procedure or Method 6 6
Patient Data Problem 6 6
Nonstandard Device 5 5
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
Incorrect Software Programming Calculations 2 2
Output Problem 2 2
Device Markings/Labelling Problem 2 2
Insufficient Information 2 2
Device Operates Differently Than Expected 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Application Program Problem: Medication Error 2 2
Use of Incorrect Control/Treatment Settings 2 2
No Device Output 1 1
Device Displays Incorrect Message 1 1
False Positive Result 1 1
Application Network Problem 1 1
Appropriate Term/Code Not Available 1 1
Protective Measures Problem 1 1
Installation-Related Problem 1 1
Product Quality Problem 1 1
Device Difficult to Program or Calibrate 1 1
Application Program Problem: Dose Calculation Error 1 1
Incorrect Or Inadequate Test Results 1 1
Problem with Software Installation 1 1
Therapeutic or Diagnostic Output Failure 1 1
Smoking 1 1
Failure to Transmit Record 1 1
Failure to Convert to Back-Up 1 1
Device Alarm System 1 1
Device Operational Issue 1 1
Communication or Transmission Problem 1 1
False Negative Result 1 1
Operating System Becomes Nonfunctional 1 1
Compatibility Problem 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 19 19
No Clinical Signs, Symptoms or Conditions 12 12
Insufficient Information 11 11
Death 5 5
No Patient Involvement 4 4
No Consequences Or Impact To Patient 4 4
No Information 3 3
Overdose 3 3
No Code Available 2 2
Sweating 1 1
Fatigue 1 1
Not Applicable 1 1
Dizziness 1 1
Palpitations 1 1
Confusion/ Disorientation 1 1
Unspecified Blood or Lymphatic problem 1 1
Swelling 1 1
Shock 1 1
Tachycardia 1 1
Toxicity 1 1
Blurred Vision 1 1
Therapeutic Effects, Unexpected 1 1
Loss of consciousness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ConvaTec, Inc II May-16-2018
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