IMPELLA RP IMPELLA RP EU 0046-0011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for IMPELLA RP IMPELLA RP EU 0046-0011 manufactured by Abiomed Europe, Gmbh.

Event Text Entries

[184814385] The complainant in the eu has not returned product for investigation. The analysis into the clinical report and data logs is on-going at this time. A final report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10


[184814386] A female patient of (b)(6) was admitted with cardiomyopathy and placed on ecmo. When she was unable to be weaned from the ecmo, the team chose to place bipella support with both an impella cp and impella rp. After 4 days of support there was note of massive hemolysis. The team chose to explant the rp. After the removal the hemolysis began to be rectified over the subsequent 3 days. The team also infuse blood products, in the form of 23 transfusions over 4 days.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220648-2020-00390
MDR Report Key9871039
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-03-13
Date Facility Aware2020-03-13
Date Mfgr Received2020-03-13
Device Manufacturer Date2019-09-18
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RALPH BARISANO
Manufacturer Street22 CHERRY HILL DRIVE
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal01923
Manufacturer Phone9786461400
Manufacturer G1ABIOMED EUROPE GMBH
Manufacturer StreetNEUENHOFER WEG 3
Manufacturer CityAACHEN 52074
Manufacturer CountryGM
Manufacturer Postal Code52074
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPELLA RP
Generic NameTEMPORARY NONROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
Product CodePYX
Date Received2020-03-24
Model NumberIMPELLA RP EU
Catalog Number0046-0011
Lot Number1434427
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerABIOMED EUROPE, GMBH
Manufacturer AddressNEUENHOFER WEG 3 AACHEN 52074 GM 52074


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-24

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