TPLC - Total Product Life Cycle

show TPLC since

Device	blood establishment computer software and accessories
Regulation Description	Blood establishment computer software and accessories.
Product Code	MMH
Regulation Number	864.9165
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALLIANCE TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
BIO-RAD MEDICAL DIAGNOSTICS GMBH
	SUBSTANTIALLY EQUIVALENT	1
BIOLIFE PLASMA SERVICES LP
	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	1
DIAGNOSTIC GRIFOLS, S. A.
	SUBSTANTIALLY EQUIVALENT	2
EDONORSOFT LLC
	SUBSTANTIALLY EQUIVALENT	1
EPIC SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GPI USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
HAEMONETICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
IMMUCOR, INC.
	SUBSTANTIALLY EQUIVALENT	3
IT SYNERGISTICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
LIFE PLASMA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAK-SYSTEM GROUP LTD.
	SUBSTANTIALLY EQUIVALENT	2
SCC SOFT COMPUTER
	SUBSTANTIALLY EQUIVALENT	1
SUNQUEST INFORMATION SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELLSKY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	11	11
Application Program Problem	6	6
Data Problem	5	5
Loss of Data	5	5
Patient Data Problem	4	4
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Application Program Problem: Parameter Calculation Error	4	4
Use of Device Problem	3	3
Inadequate User Interface	3	3
Communication or Transmission Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Date/Time-Related Software Problem	2	2
Improper or Incorrect Procedure or Method	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
Program or Algorithm Execution Failure	1	1
Therapeutic or Diagnostic Output Failure	1	1
Application Program Problem: Medication Error	1	3
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	33	35
Insufficient Information	12	12
Confusion/ Disorientation	1	1
Unspecified Blood or Lymphatic problem	1	1
Hepatitis	1	1
Viral Infection	1	1
Shock	1	1