MAUDE MDR 154781

MDR report key
154781
Report number
2435151-1998-00002
Event key
0
Event type
3
Date received
1998-03-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TUBING SYSTEM FOR PLASMAPHERESIS LT-MA2TUBING SETKANEKA CORP.MMYLT-MA2NANANRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11998-03-090

Event Narratives#

D

Patient 1

THE SHUNT-CONNECTOR OF THE LT-MA2, WHICH IS A COMPONENT OF THE LIPOSORBER LA-15 SYSTEM, WAS DETACHED FROM THE BLOOD ACCESS AND THE BLOOD WAS LEAKING.