IMPELLA 5.0 PUMP IMPELLA 5.0 PUMP SET, JAPAN 005066-JP

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 2020-03-17 for IMPELLA 5.0 PUMP IMPELLA 5.0 PUMP SET, JAPAN 005066-JP manufactured by Abiomed, Inc..

Event Text Entries

[183928682] The impella 5. 0 was discarded by the customer and therefore, investigation of device was not possible. Should any new information be returned, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[183928683] The complainant reported an (b)(6) japanese female patient had impella 5. 0 pump inserted in the right axillary for standby operation purpose. It was reported the patient developed hemolysis during pump support. The account attempted to troubleshoot the issue by changing impella's placement. The patient was also administered four units of red cell count. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220648-2020-00382
MDR Report Key9845478
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2019-12-02
Date Facility Aware2020-02-20
Date Mfgr Received2020-02-20
Device Manufacturer Date2019-02-06
Date Added to Maude2020-03-17
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 DR
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal01923
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 5.0 PUMP
Generic NameTEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
Product CodeOZD
Date Received2020-03-17
Model NumberIMPELLA 5.0 PUMP SET, JAPAN
Catalog Number005066-JP
Lot Number1391512
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerABIOMED, INC.
Manufacturer Address22 CHERRY HILL DR DANVERS MA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-17

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