FDA.reportPublic FDA data

MAUDE MDR 9857145

MDR report key
9857145
Report number
1220648-2020-00387
Event key
0
Event type
3
Date of event
2020-01-19
Date received
2020-03-19
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 OPTICALTEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMPABIOMED, INC.OZDIMPELLA CP PUMP 371 SET, US0048-00241445555N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1901. R

Event Narratives#

N

Patient 1

THE IMPELLA CP WAS NOT RETURNED BY THE CUSTOMER AND THEREFORE, INVESTIGATION OF DEVICE WAS NOT POSSIBLE. SHOULD ANY NEW INFORMATION BE RETURNED, A SUPPLEMENTAL MDR WILL BE FILED.

D

Patient 1

THE COMPLAINANT REPORTED A (B)(6) WHITE MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK FOR HEMODYNAMIC SUPPORT WITH THE IMPELLA CP OPTICAL DEVICE. DURING SUPPORT, THE PATIENT EXHIBITED SIGNS OF HEMOLYSIS VIA HEMOLYZED LABS, HOWEVER, NO PLASMA-FREE HEMOGLOBIN TESTS WERE PERFORMED TO CONFIRM. APPROXIMATELY 6 HOURS INTO SUPPORT, THE IMPELLA WAS RAPIDLY WEANED IN RESPONSE TO THE SUSPECTED HEMOLYSIS.