IMPELLA CP PUMP IMPELLA CP PUMP SET, JAPAN 0048-0034-JP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-20 for IMPELLA CP PUMP IMPELLA CP PUMP SET, JAPAN 0048-0034-JP manufactured by Abiomed, Inc..

Event Text Entries

[184416939] Device discarded by customer. The impella cp pump was discarded by the customer therefore a failure analysis investigation cannot be completed.
Patient Sequence No: 1, Text Type: N, H10


[184416940] The complainant reported a (b)(6) asian male patient had impella cp pump inserted in the right femoral for acute myocardial infarction (ami) with shock. The patient had a hemorrhage at the impella access site during pump support. As a result 14 units of red blood cells (rbcs) was administered for treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220648-2020-00389
MDR Report Key9863038
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2019-11-22
Date Facility Aware2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-09-27
Date Added to Maude2020-03-20
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, INC.
Manufacturer Street22 CHERRY HILL DR
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal Code01923
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPELLA CP PUMP
Generic NameTEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP,
Product CodeOZD
Date Received2020-03-20
Model NumberIMPELLA CP PUMP SET, JAPAN
Catalog Number0048-0034-JP
Lot Number1435812
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABIOMED, INC.
Manufacturer Address22 CHERRY HILL DR DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-20

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