FDA.reportPublic FDA data

MAUDE MDR 578523

MDR report key
578523
Report number
578523
Event key
0
Event type
3
Date of event
2005-02-15
Date received
2005-02-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*ECMO MEMBRANEMEDTRONIC PERFUSION SYSTEMSBYS***NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-02-230

Event Narratives#

D

Patient 1

AN ECMO MEMBRANE CONNECTED TO A PATIENT WAS NOTED TO BE LEAKING. THE MEMBRANE WAS CHANGED PER PROTOCOL, AND THE PATIENT CONTINUES TO REMAIN ON ECMO.THIS PARTICULAR MEMBRANE WAS REMOVED FROM SERVICE, AND WILL BE RETURNED TO THE VENDOR. HOWEVER, THIS TYPE OF MEMBRANE DOES CONTINUE TO BE USED AT THE HOSPITAL.