FDA.reportPublic FDA data

MAUDE MDR 7713645

MDR report key
7713645
Report number
7713645
Event key
0
Event type
3
Date of event
2018-06-13
Date received
2018-07-24
Adverse event
0
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
1IMPELLATEMPORARY NON-ROLLER TYPE CARDIAC SUPPORT BLOOD PUMPABIOMED, INC.PBLNOT KNOWNNOT KNOWN* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-240

Event Narratives#

D

Patient 1

PATIENT'S IMPELLA CP ALARMED "LOW PURGE PRESSURE". ALL CONNECTIONS BOTH TO THE PATIENT AND TO THE PRESSURE BAG/PURGE FLUID BAG WERE CHECKED TO MAKE SURE THERE WERE NO LEAKS OR KINKS. STAFF THEN NOTICED A SMALL PUDDLE UNDER THE IMPELLA CONTROLLER, AND UPON OPENING THE CASSETTE FLAP NOTED THAT THERE WAS A LEAK IN THE CASSETTE SOMEWHERE. IT APPEARED TO BE LEAKING TO THE RIGHT OF THE CASSETTE FROM THE SMALL CIRCULAR MEMBRANE. STAFF QUICKLY USED THE SPARE CASSETTE AND OLD PURGE FLUID BAG AND SWITCHED OUT THE CASSETTE. NO HARM TO THE PATIENT.