FDA.reportPublic FDA data

MAUDE MDR 9871244

MDR report key
9871244
Report number
1220648-2020-00391
Event key
0
Event type
3
Date of event
2020-02-22
Date received
2020-03-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. RALPH BARISANO
Address
22 CHERRY HILL DR DANVERS MA 01923 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPELLA CP PUMPTEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMPABIOMED, INC.OZDIMPELLA CP PUMP SET, JAPAN0048-0034-JP1453002R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2401. R

Event Narratives#

N

Patient 1

THE IMPELLA CP IS EXPECTED TO BE RETURN. A SUPPLEMENTAL MDR WILL BE FILED WITH THE RESULTS OF THE INVESTIGATION, UPON COMPLETION.

D

Patient 1

THE COMPLAINANT REPORTED A (B)(6) JAPANESE MALE PATIENT HAD IMPELLA CP PUMP INSERTED IN THE RIGHT FEMORAL FOR CARDIOMYOPATHY. IT WAS REPORTED THE PHYSICIAN SUSPECTED HEMOLYSIS DURING PUMP SUPPORT. PFHG LEVELS WERE NOT PROVIDED. PUMPS FLOWS WERE LOWERED; HOWEVER, THERE WAS NO IMPROVEMENT. AS A RESULT, TREATMENT WAS ESCALATED TO 5.0. NO FURTHER INFORMATION WAS PROVIDED.