FDA.reportPublic FDA data

MAUDE MDR 7605553

MDR report key
7605553
Report number
1722028-2018-00177
Event key
0
Event type
3
Date of event
2018-05-24
Date received
2018-06-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEVE KERN
Address
10810 W. COLLINS AVE. LAKEWOOD CO 80215 US
Phone
303-303-3032
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
13ME-SC203A TSCDII 110VTSCDII 110VTERUMO BCTKSB3MESC203AR R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-1501. O

Event Narratives#

N

Patient 1

INVESTIGATION: PER CUSTOMER THE WELDS LOOKED "CHARRED"AND THEY FOUND THAT THE WAFER IN THE BOX WAS BENT, PREVENTING THE WAFER FROM ADVANCING. A USED WAFER AND PARTIALLY CONSUMED CARTRIDGE WAS RECEIVED BY TERUMO BCT FOR EVALUATION. TO AVOID RISK OF EXPOSURE, THE CARTRIDGE AND WAFER REMAINED WITHIN THE BIOHAZARD BAG DURING VISUAL INSPECTION. UPON VISUAL INSPECTION, IT WAS FOUND THAT THE USED WAFER HAD A VISCOUS AND BURNT MATERIAL ON EACH SIDE. ONE SIDE SHOWED THE MATERIAL IN A RECTANGULAR SHAPE AND APPEARED MOSTLY AMBER WITH SOME DARKER BROWN AREAS NEAR THE MIDSECTION OF THE WAFER. THE OTHER SIDE SHOWED TWO DISTINCT CIRCULAR AREAS WHERE THE MATERIAL HAD SETTLED ONTO THE WAFER WHICH WERE ALSO AMBER IN COLOR AND SLIGHTLY DARKER IN SOME AREAS, LIKELY DUE TO EXCESSIVE HEATING. A HORIZONTAL LINE WAS OBSERVED WITHIN THE WAFER MATERIAL ON THIS SIDE THAT WAS MORE DEEPLY CUT INTO THE COPPER MATERIAL THAN ON THE OTHER SIDE. THERE WAS NO OBSERVABLE BOWING OR DENTING OF THE WAFER THAT HAD BEEN USED. THE CARTRIDGE WAS CLOSELY INSPECTED AND FOUND TO HAVE A BENT WAFER THAT WAS IMPEDING IT FROM ADVANCING. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

D

Patient 1

THE CUSTOMER REPORTED THAT WHILE WELDING TUBING TO CREATE A SPLIT UNIT OF AN AUTOLOGOUS STEM CELL COLLECTION, THE WELDER DID NOT EJECT THE WAFER AND MULTIPLE WELDS WERE CREATED USING THE SAME WAFER. THE CUSTOMER STATED THAT ONE OF THE UNITS HAD TESTED (B)(6) FOR (B)(6). THERE WERE 2 DONORS WITH 3 DONATIONS INVOLVED AND A TOTAL OF SIX PRODUCTS ALIQUOTED AND FROZEN. PER THE CUSTOMER, NONE OF THE UNITS WERE TRANSFUSED. UNIT (B)(6) - SPLIT UNIT (SECOND PRODUCT) THE CUSTOMER DECLINED TO PROVIDE THE DONOR AGE,GENDER, WEIGHT AND OUTCOME.