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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
ALLIANCE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
ARC-ONE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMAT USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIQ-HEALTH SOLUTIONS, LDA
  SUBSTANTIALLY EQUIVALENT 1
CARTER BLOODCARE
  SUBSTANTIALLY EQUIVALENT 2
CSL PLASMA
  SUBSTANTIALLY EQUIVALENT 1
DATA INNOVATIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPARTMENT OF VETERANS AFFAIRS
  SUBSTANTIALLY EQUIVALENT 1
EPIC SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HEADSPRING HEALTHCARE, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMASOFT SOFTWARE SL
  SUBSTANTIALLY EQUIVALENT 2
KEDRION S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MAK-SYSTEM SA INTERNATIONAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INFORMATION TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIWARE INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCC SOFT COMPUTER
  SUBSTANTIALLY EQUIVALENT 2
STRATEC BIOMEDICAL UK LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SUNQUEST INFORMATION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SYSLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 2
WELLSKY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 8 8
2018 12 12
2019 10 10
2020 3 3
2021 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 9 9
Application Program Problem 6 6
Nonstandard Device 5 5
Improper or Incorrect Procedure or Method 4 4
Patient Data Problem 4 4
Data Problem 3 3
Use of Device Problem 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Device Markings/Labelling Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Problem with Software Installation 1 1
Programming Issue 1 1
Appropriate Term/Code Not Available 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Compatibility Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Application Network Problem 1 1
Loss of Data 1 1
Device Difficult to Program or Calibrate 1 1
Failure to Transmit Record 1 1
Use of Incorrect Control 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
No Known Impact Or Consequence To Patient 13 13
Insufficient Information 8 8
No Patient Involvement 4 4
Death 4 4
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
No Information 2 2
Not Applicable 1 1
Loss of consciousness 1 1
Sweating 1 1
Palpitations 1 1
Fatigue 1 1
Overdose 1 1
Swelling 1 1
Tachycardia 1 1
Blurred Vision 1 1
Dizziness 1 1

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