TPLC - Total Product Life Cycle

• Device: centrifuges (micro, ultra, refrigerated) for clinical use
• Product Code: JQC
• Regulation Number: 862.2050
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
EMCYTE CORPORATION
	SE - WITH LIMITATIONS	1

MDR Year	MDR Reports	MDR Events
2018	10	10
2019	7	7
2020	4	4
2021	1	1
2022	1	1
2023	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	7	7
Detachment of Device or Device Component	3	3
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Device Expiration Issue	2	2
Material Fragmentation	2	2
Insufficient Information	2	2
Inadequate User Interface	2	2
Infusion or Flow Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Appropriate Term/Code Not Available	1	1
Noise, Audible	1	1
Incomplete or Inadequate Connection	1	1
Difficult to Open or Close	1	1
Burst Container or Vessel	1	1
Crack	1	1
Mechanical Problem	1	1
Delivered as Unsterile Product	1	1
Unsealed Device Packaging	1	1
Smoking	1	1
Device Stops Intermittently	1	1
Component Missing	1	1
Device Contamination with Body Fluid	1	1
Device Issue	1	1
Obstruction of Flow	1	1
Sparking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	8	8
No Clinical Signs, Symptoms or Conditions	7	7
No Patient Involvement	5	5
Death	2	2
Injury	2	2
Electric Shock	1	1
Incomplete Induced Abortion	1	1
No Information	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	LW Scientific, Inc.	II	Mar-23-2019