FDA.reportPublic FDA data

MAUDE MDR 7430635

MDR report key
7430635
Report number
1066733-2018-00008
Event key
0
Event type
3
Date of event
2018-02-26
Date received
2018-04-13
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
MS. JESSICA HUGHES
Address
3948-A WESTPOINT BLVD. WINSTON SALEM NC 27103 US
Phone
336-336-3367
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
130-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINERCHARTER MEDICAL, LTD.LPZCF-250CF-250150297R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-130

Event Narratives#

N

Patient 1

THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/REVIEW. HOWEVER, A PICTURE OF THE BAG WAS FORWARDED BY THE USER FACILITY.THE BAG LOT NUMBER, LOT 150297, WAS VISIBLE FROM THE PICTURE. THE PICTURE INDICATED A BAG WITH AN OPEN INLET TUBE AND THERE WAS NO VISIBLE EVIDENCE OF A USER APPLIED SEAL ON THE INLET TUBE. THE STANDARD METHOD OF USE FOR THE CF-250 IS FOR THE USER TO FILL THE BAG, APPLY A SEAL ON THE INLET TUBE, AND DISCARD THE REMAINING UN-NEEDED TUBING. THE BAG IS THEN FROZEN. THERE ARE ONE OF TWO POTENTIAL SCENARIOS: - THE USER'S TUBE SEAL FAILED. - THE TUBE BROKE BELOW THE USER APPLIED SEAL AFTER THE BAG WAS FROZEN. THE REPORTED LEAK DID NOT OCCUR DURING FILLING OF THE BAG OR DURING THE FREEZING PROCESS, WHICH SUGGESTS THE INLET TUBE BREAK LIKELY OCCURRED AFTER THE BAG WAS FROZEN. THERE WAS NO ADDITIONAL INFORMATION TO SUGGEST AN EXACT ROOT CAUSE FOR THIS REPORT. THERE ARE SEVERAL POTENTIAL ISSUES WHICH COULD CONTRIBUTE TO A FAILURE MODE OF THIS NATURE. - RESIDUAL MOISTURE ON THE OUTSIDE OF THE BAG WHEN IT WAS PLACED INSIDE THE CASSETTE. RESIDUAL MOISTURE COULD CAUSE THE INLET TUBE TO FREEZE/ADHERE TO THE CASSETTE DURING THE FREEZING PROCESS. A CONDITION OF THIS TYPE COULD CAUSE TUBE DAMAGE UPON REMOVAL OF A FROZEN BAG FROM THE CASSETTE. - HANDLING OF THE BAG IN THE FROZEN STATE. THE FILM AND INLET TUBE OF A FROZEN BAG IS FRAGILE - INADVERTENT MANIPULATION OR IMPACT ON THE BAG COULD CAUSE THE INLET TUBE TO FRACTURE. PRECAUTIONS TO HELP PREVENT ISSUES INDICATED ABOVE ARE ADDRESSED IN THE PRODUCT IFU'S.

D

Patient 1

ON (B)(6) 2018, AFTER THE TECHNICIAN THAWED THE BAG CONTAINING AUTOLOGOUS CELL PRODUCT, A LEAK WAS DETECTED FROM A BROKEN BAG FILLER TUBE. A USER SEALED SEGMENT OF THE TUBE WAS DETACHED FROM THE BAG. THE TECHNICIAN CLAMPED THE REMAINING PORTION OF THE FILLER TUBE TO PREVENT ADDITIONAL LEAKING. THE BAG INITIALLY CONTAINED APPROXIMATELY 60ML OF CELL PRODUCT. THE TECHNICIAN WAS ABLE TO RECOVER 49ML OF CELL PRODUCT, WHICH WAS INFUSED INTO A PATIENT. TOTAL CD34/KG CELLS INFUSED WAS 2.061 E6 INSTEAD OF 2.16 E6 CELLS THAT SHOULD HAVE BEEN INFUSED.