Trima Accel Platelet and Multiplasma Sets (2019-12-19)
- Starting date:
- December 19, 2019
- Posting date:
- February 28, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72417
Last updated: 2020-03-06
Affected Products
- Trima Accel Platelet, Plasma, Auto RBC Set
- Trima Accel Platelet + Sampler, Plasma, Auto RBC Set
- Trima Accel Auto RBC, Plasma Set
- Trima Accel RBC, Plasma Set
- Trima Accel RBC, + TLR, Plasma Set
- Trima Accel LRS Platelet, Plasma, RBC Set
- Trima Accel Enhanced Platelet, Plasma RBC Set
- Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set
- Trima Accel Platelet Multiplasma, RBC, Autopas Set
- Trima Accel Platelet + Sampler, Multiplasma, RBC Set
- Trima Accel LRS Platelet, Plasma, Auto RBC Set
- Trima Accel LRS Platelet + Sampler, Plasma, Auto RBC Set
- Trima Accel LRS Platelet + Auto Pas, Plasma, Auto RBC Set
- Trima Accel LRS Platelet + Sampler, Plasma, RBC Set
- Trima Accel, Multiplasma Set
- Trima Accel LRS Platelet + Sampler, Multiplasma, RBC Set
Reason
Complaints have been received by Terumo BCT for pressure test error alerts that are associated with inflation and pressurization of the sample bag. A new sample bag line clamp was introduced in early 2019 to mitigate the issue. There has been an increase in the frequency of complaints for the issue since the introduction of the new clamp, including one incident in which air was infused into a donor. Root cause investigation identified two potential causes for the failure of the new sidewall clamp.
Affected products
A. Trima Accel Platelet, Plasma, Auto RBC Set
Lot or serial number
All lots.
Model or catalog number
- 80350
- 80356
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
B. Trima Accel Platelet + Sampler, Plasma, Auto RBC Set
Lot or serial number
All lots.
Model or catalog number
- 80360
- 80366
- 80470
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
C. Trima Accel Auto RBC, Plasma Set
Lot or serial number
All lots.
Model or catalog number
- 80520
- 82520
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
D. Trima Accel RBC, Plasma Set
Lot or serial number
All lots.
Model or catalog number
- 80500
- 82500
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
E. Trima Accel RBC, + TLR, Plasma Set
Lot or serial number
All lots.
Model or catalog number
80550
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
F. Trima Accel LRS Platelet, Plasma, RBC Set
Lot or serial number
All lots.
Model or catalog number
- 80400
- 80406
- 82400
- 82406
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
G. Trima Accel Enhanced Platelet, Plasma RBC Set
Lot or serial number
All lots.
Model or catalog number
- 80440
- 80446
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
H. Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set
Lot or serial number
All lots.
Model or catalog number
80450
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
I. Trima Accel Platelet Multiplasma, RBC, Autopas Set
Lot or serial number
All lots.
Model or catalog number
80700
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
J. Trima Accel Platelet + Sampler, Multiplasma, RBC Set
Lot or serial number
All lots.
Model or catalog number
80340
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
K. Trima Accel LRS Platelet, Plasma, Auto RBC Set
Lot or serial number
All lots.
Model or catalog number
- 82650
- 82656
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
L. Trima Accel LRS Platelet + Sampler, Plasma, Auto RBC Set
Lot or serial number
All lots.
Model or catalog number
- 82616
- 82660
- 82666
- 82668
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
M. Trima Accel LRS Platelet + Auto Pas, Plasma, Auto RBC Set
Lot or serial number
All lots.
Model or catalog number
82470
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
N. Trima Accel LRS Platelet + Sampler, Plasma, RBC Set
Lot or serial number
All lots.
Model or catalog number
- 82440
- 82446
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
O. Trima Accel, Multiplasma Set
Lot or serial number
All lots.
Model or catalog number
82700
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES
P. Trima Accel LRS Platelet + Sampler, Multiplasma, RBC Set
Lot or serial number
All lots.
Model or catalog number
- 82408
- 82416
Companies
- Manufacturer
-
Terumo BCT Inc.
10811 W. Collins Avenue
Lakewood
80215
Colorado
UNITED STATES